Jobs That Crossed My Desk, Feb. 9-20, 2009Contact the person whose information appears at the top of each listing. Listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines.

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If interested,Please contact Patti.

Patti Henderson-O'ConnellPresident/OwnerO'Connell Search International17106 Vose St.Lake Balboa, CA 91406818-675-6465

I have a new opening for Surgi-Vision in Irvine. Electrical EngineerBS or MS up to 160K depending on experience--must have Medical Deviceand RF experience--- MRI and Catheter experience a plus. Very strongTechnically. Please let me know if you would be interested or know ofsomeone who may be

Send Resumes to Thomas SchmidEmail Tom@bluechipsearch.comPhone 877-258-7724 ext 105Position Location: San Francisco

Thomas SchmidSenior RecruiterOffice: 760-547-2177 ext 105Toll Free: 877-258-7724Fax: 877-231-9771

www.bluechipsearch.comhttp://www.linkedin.com/in/tschmid949

Director, Business Development / Sales Our client is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. The company meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.  

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Currently, we are experiencing significant growth and are conducting a search for sales candidates in the San Francisco area. Reporting directly to the Senior Director within our Business Development Department, the Business Development Director's primary responsibilities will include the following:

·        Building and executing business plan for achieving quarterly and annual revenue and pipeline objectives

·        Identification and prospecting of new business leads, including qualification and needs assessments

·        Presentation and positioning of marketing and sales solutions to prospective client executives (outsourced professional services)

·        Developing effective proposals and persuasively closing new business opportunities ·        Maintaining client relationships and building new business relationships ·        Management of territory and named accounts ·        Strategic ability to identify needs and problem solve for clients ·        Coordination with regional director, project teams, and team leads/project managers ·        Coordination with business groups for staffing and proposal/project development ·        Identification of up-sell opportunities ·        Provide lead generation and RFP generation

The successful candidate will have a combination of the following skills/experience: ·        Living in SF/Bay area (preferred) ·        BA/BS degree required (Business or Life Science related degrees preferred) ·        Minimum of 5-7 years professional experience selling software and/or services into the Life

Science Industry (Pharmaceutical, Biotech, Clinical Research) ·        SF.com knowledge a plus ·        Knowledge of all MS Office applications required ·        Excellent written and oral communication skills ·        Self motivated determined individual with a track record for success ·        Strong sales skills & ability to work with CXO-level executives ·        Willingness to travel up to 100%

The company is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made them an employer of choice, and one of the most sought after Life Sciences employers in the area.

ContactJarboe & Associates janetjarboe@qwest.net(office) 970-669-2600 970-689-2962 (mobile

not listed - OPPORTUNITIES FOR MEDICAL DOCTORS - please call for details

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Senior Scientist lll– Clinical Pharmacokinetics (full description available soon-please contact) TexasRequires a Master's and 9 years of experience or a PhD and 6 years experience.

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Must be familiar with and very comfortable with NONMEM, simulation, PK modelingAssociate Director / Clinical Team Leader, Clinical Pharmacokinetics Texas

Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential

Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis.

Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives.

Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.

Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives.

Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies.

Submits and administers employee performance standards and actively develops personnel within the team.

Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects.

Represents Clinical Pharmacology at various clinical meetings and project team meetings.

Principle Responsibilities:

Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.

Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.

Provide effective and timely mentoring and support for subordinates.

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Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.

Additional (enhancing) skills:

Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation. Familiarity with relevant company SOPs and document management systems. Good knowledge of GCP requirements. Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills.

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Associate Director, Regulatory Affairs__________________________________________________________Illinois

Responsible for representing the department on project teams, and collaborating on the development of regulatory strategies (e.g., NDA/BLA strategy) with management oversight; driving submission related activities and successfully executing regulatory strategies. Responsible for significant interactions outside the Regulatory Affairs department on complex issues including interaction with regulatory authorities.Position Requirements: *Bachelor's degree in scientific discipline; advanced degree preferred. *At least 8-10 years industry experience, 6 years in Regulatory Affairs preferred. *Recognized as experienced in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope. *Scientific knowledge in chemistry, general biology/physical sciences, or health sciences, and ability to apply knowledge to regulatory issues and pharmaceutical product development and to deal with in-depth technical information from a variety of disciplines. *Comprehensive knowledge of the drug development process and life cycle management and application to current and evolving regulatory requirements associated with assigned products and therapeutic/technical areas. This should also include experience with global regulatory projects. *Strong organizational skills with the ability to manage multiple complex projects in a matrix environment. *Excellent written and verbal communication skills. Ability to communicate effectively with peers, technical experts, scientists, senior staff, and regulatory authorities to present scientific/regulatory case and foster high degree of credulity with regulatory authorities *Experience managing others preferred.

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Clinical Program Manager (Anemia)____________________________________________________ California

Description:

*Reporting to the Associate Director, manage the implementation of clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines *Coordinate and oversee the internal activities for each study in terms of

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clinical, data management, biometrics, drug safety, regulatory, and clinical supplies activities *Write clinical trial protocols and amendments *Manage the preparation of Informed Consent Forms *Assist in the design and development of and approval of Case Report Form development *Coordinate team review of tables, figures, and listings *Working with Clinical Contracts and Outsourcing, select service providers, review and approve of site and service provider budgets and scope of work

Oversee management of service provider activities including CROs, contract regional CRA monitors, data management, biometrics, central and specialty laboratories, and IWRS/IVRS *Address and seek resolution of administrative issues with investigational sites or service providers. *Escalate issues to the Associate Director as needed *Manage service provider budgets and invoices *Directly manage in-house CRAs in terms of administrative and project performance *Forecast and manage the investigational product needed for the conduct of clinical trials *Manage and ensure investigational product accountability *Develop clinical monitoring plans and establish study monitoring priorities *Develop and maintain cross-functional study timelines using MS Project *In partnership with the Associate Director, Medical Monitor, Biostatistician, and Drug Safety, assist in the preparation of Clinical Study Reports, product Investigator Brochure, IND Annual Reports, expedited or annual safety reports

Job Requirements:

A minimum of 7 years of experience as a CRA in a pharmaceutical or biotechnology company with the first five years of progressive CRA responsibilities and at least the last two years in a management role *Knowledge of FDA regulatory requirements and competence in ICH/GCP guidelines *Knowledge of clinical trial methodology *Demonstrated proficiency in the implementation, maintenance, and closure of clinical trials *Demonstrated managerial and supervisory skills

Demonstrated ability to work effectively with cross-functional project team members (regulatory affairs, QA, marketing/business *development, research, project management, etc) *Excellent written and oral communication and analytical skills *Demonstrated experience in managing international studies; experience with East Asia a plus *Computer proficiency in MS Word, Excel, Project, Power Point, and Outlook; MS VISIO a plus

Education:

Bachelor's degree in a scientific or health-related field

Languages:

English - excellent command of English, written, oral and in presentations

Mandarin – Ability to speak, write and type a plus

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Senior Clinical Contracts Associate_________________________________________________________California

Responsibilities:

The Senior Clinical Contracts Associate's primary responsibilities shall include but are not limited to the preparation, negotiation, tracking and finalization of the clinical trial agreements and confidentiality agreements inclusive of the site budget within the clinical trial agreement.

This position reports to the Associate Director, Clinical Contracts and Outsourcing.

Specific duties Draft and track status of clinical trial agreements, amendments and confidentiality agreements with site specific information and e-mail to sites Status the sites regarding outstanding agreements and budgets, and provide weekly updates to clinical team Process all agreements for execution, ensuring that the appropriate departments within company receive a copy

Ensure that all budget approvals, correspondence, invoices and fully executed contracts are filed within the clinical contracts filing system and ensure files are audit ready Track all fully executed clinical agreements and invoices

Update the financial spreadsheets for each study/site Liaise with clinical for monthly site accruals Pay, track and reconcile all payments to investigator sites Responsible for the development of site budget templates from the Schedule of Assessments Negotiate directly with the sites regarding budgets and contract language Liaise with legal for review of contract language Mentor Clinical Contract Associates and may have a supervisory role Ability to negotiate global clinical trial agreements and budgets Ability to establish, draft and train with respect to process documents

Requirements: BS/BA in Business Administration, finance or related discipline, or equivalent education plus experience At least four (4) years of site budget and contract negotiation experience Minimum of 5-7 years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR) Excellent negotiation and written/verbal communication skills Ability to work independently, creative thinking and problem solving skills Ability to understand the full clinical development process Must understand the "Sponsor of Choice" philosophy Must have good organization and planning skills, proven ability to handle multiple priorities and work independently Must be a team player and be a leader within the department Proficiency with MS Word, Excel, Access and Outlook required

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Senior Clinical Research Associate_____________________________________________________ ___California

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The Sr. Clinical Research Associate (CRA) will be responsible for initiation, monitoring and other tasks associated with clinical studies. The Sr. CRA will also be responsible for investigational site management for clinical studies and will assist in the creation of an implementation of protocols, informed consents, case report forms, clinical study reports and related study materials. He/she will also provide guidance, clinical trial management and direction to contract CRAs in the field.

Responsibilities:

The Senior CRA will actively participate in clinical trial activities from study start through closure Assist the CPM with vendor management, including the CRO (monitoring and data management), central laboratory and IVRS vendors Work with CRO and manage site selection process Assist with reviewing and editing study documents such as Study Operations Manual, Study Drug Manual, Project Management Plan, Communication Plan, Monitoring Plan and Data Management Plan Prepare and review study tools such as Source Document Worksheets and Source Data Verification Worksheets Assist with protocol development, study design completion and designing CRFs Accompany CRO/CRAs to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols Order and coordinate study supplies Develop and maintain tracking tools Assist with CRO selection and management of CROs and other vendors May assist with site budget negotiations Plan and participate in investigator meetings Assist and support data validation and data clean procedures

Assure regulatory compliance of investigational sites with SOPs and FDA and ICI guidelines

Requirements: BS in Life Sciences or health-related field Minimum of 5 years experience as a CRA including monitoring of sites and in-house CRA study management Minimum of 2 years in-house experience Some experience in protocol writing and informed consent development Experience in study site selection, site budget development / negotiation and overall site management Some experience in vendor (CRO, central laboratory, IVRS, EDC) selection and overall vendor management (CROs and preferably IVRS) Willing to travel as needed (Minimal travel)

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(Senior) Clinical Program Manager (Fibrosis) California

My client seeks a Clinical Program Manager / Sr Clinical Program Manager for our Connective Tissue Growth Factor (CTGF) Fibrosis Program, to manage trials for subjects with diabetic nephropathy and chronic kidney disease who will enroll into our developing FGCL-3019 (monoclonal antibody) program. Reporting to an Associate Director, specific responsibilities include:

Manage clinical studies to ensure that they are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines

Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports

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Manage study sites and train clinical site staff to ensure protocol and regulatory compliance.

Responsible for clinical site budget development

Responsible for CRO selection and assist in the development of RFPs.

Manage the Contract Research Organizations (CROs) responsible for the conduct of clinical studies

Manage the activities of vendors, including clinical services, data management, biostatistical services, and central laboratory services

Manage clinical personnel, including in-house and contract Clinical Research Associates (CRA)

May be responsible for ensuring SOP and regulatory compliance of staff

Assists in CRO selection, development of RFPs, budget negotiations, and provides CRO management overall.

Assists in the development and writing of study protocols, study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA). Interact with investigators and thought leaders for protocol development, presentations and publications.

Coordinate and participate in investigator meetings.

Mentor and develop junior staff. May manage and direct junior staff

Estimate and manage the clinical supplies needed for the conduct of clinical trials

Develop clinical monitoring plans and establish study monitoring priorities

Address and seek resolution of administrative issues with investigational sites and/or CROs

Requirements:

Bachelor’s degree in a relevant scientific discipline or equivalent. 8+ years of relevant clinical experience in the pharmaceutical industry or equivalent.

Knowledge of GCP and ICH guidelines required.

Proficiency in the implementation, monitoring, and management of clinical trials

Demonstrated managerial and supervisory skills

Excellent communication and interpersonal skills. Detail oriented.

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Able to problem solve and use good judgment.

Able to work within a team. And work with general instructions.

Proficiency with MS Word, Excel, Outlook, and PowerPoint. Microsoft Project skills preferred.

Must be willing to travel as required for the project (approx. 10%)

Clinical QA, Sr. Specialist / Clinical QA, Manager_______________________________________________ColoradoRequirements:BS in biological, life sciences, or equivalent experience. 3 years experience in GCP QA for Sr. Specialist, 5 years experience in GCP QA for Manager. Additional experience in GLP and/or GMP QA, a plus. The ability to travel up to 25%. Excellent diplomatic, analytical and communication skills, both verbal and written. Detail oriented with proven organizational and leadership skills.Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.Must be proficient in Word, Excel and PowerPoint. Description:-Responsible for evaluating the compliance of clinical trials conducted by company to US FDA regulations and ICH guidelines, as well as corporate policies and standard operating procedures.Responsibilities:-Support Clinical Research Department by evaluating Clinical Study compliance with FDA Good Clinical Practice regulations and ICH guidelines through internal and external audits.-Plan, conduct and report GCP audits of clinical investigators, vendors, systems, and key reports and documents. Monitor audit responses and corrective action to assure accuracy and consistency.-Participate in development and review of GCP QA SOPs and review of other SOPs & forms supporting company’s GCP activities. -Participate in the planning, developing, delivery and documenting of comprehensive GCP training programs to company personnel involved in or supporting GCP activities. Assist in development and delivery of GCP training materials at Investigator Meetings.-Represent GCP QA on appropriate clinical study teams to facilitate audit planning and timely GCP advice, as directed by GCP QA Management.-Facilitate regulatory inspections of company facilities and provide appropriate support for inspections of company’s clinical sites and vendors, as needed.-Implement and maintain appropriate CQA files of all audit and inspection activities-Keep CQA Management apprised of compliance and personnel issues through periodic reports.-Maintain good working relationships and communication with GCP QA customers including Clinical Development, Regulatory Affairs and company GXP QA staff.

Regulatory Affairs Programs Mgr / Sr. Reg Affairs Programs Mgr_________________________________ColoradoRequirements:BA/BS degree in a scientific/health sciences discipline 5-7 years experience in pharmaceutical Regulatory Affairs (title will be determined by experience)Experience in the management and preparation of regulatory agency submissions

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Experience working with regulatory agenciesAbility to communicate effectively (written and verbal) and adapt to a changing environmentDescription:We have 2 openings for either a Regulatory Affairs Program Manager or a senior level Program Manager. These positions will report into Regulatory Affairs within the Clinical Development department and will have interaction with preclinical, clinical and chemistry, manufacturing and controls personnel. Responsibilities:• Participating in the development and implementation of regulatory strategy for one or more projects and ensure successful regulatory filings. • Working in a team environment and planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration.• Representing the department on multidisciplinary product development teams.• Assessing and communicating regulatory requirements for clinical, preclinical and CMC submissions and programs to assure that all development activities are in compliance with applicable the US and pertinent international regulations and guidelines. • Coordinating and supporting the writing of INDs, Canadian CTAs, IMPDs and ROW investigational applications with an emphasis on Phase 1 and Phase 2 development stages. Must be “hands-on” and willing to take on projects and tasks to support project teams.• Serving as the primary contact with regulatory agencies and CROs and facilitating communication between the agencies and project teams. • Attending and/or chairing agency meetings. • Writing regulatory agency meeting minutes and assisting in the preparation of briefing documents.• Ensuring timely submission of appropriate regulatory documents individually, as a regulatory team, or through contract organizations.• Maintaining compliance with regulatory commitments.• Working efficiently and effectively within regulatory teams, fostering collaborative exchanges, teamwork, and mentoring of colleagues. • Managing, prioritizing and dividing tasks to ensure all submissions are on time.• Writing regulatory SOPs and ensuring SOPs are in compliance with current regulatory requirements.• Working with Regulatory Operations to develop submissions in electronic and legacy format.

Early phase (I II) experience, Experience with IB's and protocols, CMC helpful

Associate Director/ Director - Ocular Drug Delivery___________________________________MassachusettsRequirements: Ph.D., MS or Bachelor’s degree in Pharmacy, Chemistry, or related field, advanced degree preferredMinimum of 5-10 years experience in formulation development in the pharmaceutical or biotechnology industry, with ophthalmic formulation experience highly desirable.Working knowledge of applicable GMPsA history of creative problem solving in the formulation area.Excellent written and verbal communication skills and presentation skills.Previous management experience in a laboratory environment with formulation CRO management highly desired.

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Ability to work effectively in a dynamic team environmentJob Responsibilities and Accountability:Assist the Core Project Team in the determination of overall drug development strategy, through in depth understanding of the formulation requirements and technical constraints Design of formulation development plans for ophthalmic and non-ophthalmic drug delivery, including pre-formulation, process development and validation, and clinical trial material manufacturing Management of formulation development plans including compliance with time lines and assigned budgetCommunication of all formulation-related information including strategy, progress against plan, timing and budget issues to Core Project Team and Management Team.Identification, evaluation and contracting of required external formulation expertise and capacity, to meet strategic development goalsAct as the primary communication point and manager of all contracted vendors in the formulations area Oversee the design and planning of all experiments, and supervise contracted formulation scientists, including review and finalization of technical reports with assigned vendors. Development and manufacture of all formulated drug for clinical (GMP) and non-clinical (GLP and non-GLP) useResponsible author for drug product CMC sections of all regulatory submissionsDevelop analytical methods and stability protocols required for the characterization and stability testing of drug products.Remain current in GMPs and commit to Company’s Quality Policy in related areas. Facilitate technical transfer of drug product manufacturing processes from formulation development to manufacturing vendors/CROs.Other duties as assigned._______________________________________________________________________________________________Senior Scientist lll– Clinical Pharmacokinetics (full description available soon-please contact) TexasRequires a Master's and 9 years of experience or a PhD and 6 years experience. Must be familiar with and very comfortable with NONMEM, simulation, PK modeling________________________________________________________________________________________________

Associate Director / Clinical Team Leader, Clinical Pharmacokinetics Texas

Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives.

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Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. Submits and administers employee performance standards and actively develops personnel within the team.Provides timely and quality documents (i.e., protocols, clinical study reports (Scars), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. Represents Clinical Pharmacology at various clinical meetings and project team meetings.Principle Responsibilities:Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.Provide effective and timely mentoring and support for subordinates. Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.Additional (enhancing) skills:Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation.Familiarity with relevant company SOPs and document management systems

Good knowledge of GCP requirements.

Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. Excellent written and oral communication skills.Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.

Medical Director, Medical Affairs Responsible for: the development of P3b/P4 studies and medical monitoring for SL studies; enhancing scientific relationships with key opinion leaders; reviewing promotional and educational material for accuracy; leading consultant and advisory meetings; and reviewing grant applications for scientific merit. Responsibilities will also include ensuring strategic alignment among functional groups within Medical Affairs; regular interactions with senior product and clinical management for strategic development issues and marketing operations; and contributing to life-cycle management. This person will contribute as a medical director to product specific and therapeutic area functions such as publications, medical information, medical education, and consultancy and advisory boards. This person will be responsible for development of post-marketing clinical development plans including design of P3B, P4 studies. They will assist the commercial team in development and

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communication of consistent global and regional brand messaging across indications. They will provide technical scientific/medical consultation to the commercial team to ensure accuracy and compliance with Astellas standards. They will help to develop phase IIIb/IV clinical trial needs and strategies to support brand. They will assist in the development and execution of brand publication strategies. Effective performance of activities requires minimal supervision or guidance by the Vice-President of Medical AffairsM.D. degree, Board Certified or Board Eligible in Designated Specialty (preferred) or a PhD with subject matter expertise in Urology or ImmunologyPosition RequirementsMinimum three years clinical or clinical research experienceMinimum one year experience in the pharmaceutical industryExcellent communication and presentation skills, strong interpersonal skills.Strong clinical research/medical affairs background, and excellent problem solving abilities.Demonstrate abilities to work effectively in a team environment.Ability to interpret and evaluate clinical data. Leadership skills and ability to effectively manage projects and timelines. Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development. Knowledge of FDA, other regulatory agency and professional requirements, regulations and guidancesAble to work independently on all aspects of assigned projectsExcellent organizational skills

Sr SAS Programmer Responsible for providing all required SAS programming functions. Responsible for working with project statistician to design tables, listing, graphs, and statistical summaries. Responsible for coordinating all programming activities for assigned projects. Responsible for completing quality assurance and validation procedures on assigned SAS programs. Responsible for developing SAS applications using higher level SAS features.Codes, tests and documents the development of SAS programs that generate output in conformance with defined specifications of tables/listings/graphs and other programs as assigned by manager.Creates study databases following the study database specifications as directed.Performs quality assurance checks and validation of SAS programs and prepares documentation of results.Serves as the lead programmer/analyst on assigned projects and co-ordinates activities of all SAS personnel on the project.Develops, modifies, test, validates, and documents SAS Macro procedures for standardized tables and graphical summaries.Runs programs and prepares program output for reviews and study reports.Reviews statistical analysis plan components (IAP, TLG shells, DDR, etc).Participate in the creation of study database specifications with project statisticians.Creates and tests programs for the import and export of SAS datasets.Participates on multidisciplinary project teams

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Works with Data Management personnel to develop SAS programs that aid in the data review and editing activities.  Minimum requirements are:

MS in Statistics, Biostatistics or equivalent experience and at least 3 years experience using the SAS system to summarize clinical trial data, or a BA degree in a quantitative field or equivalent experience and at least 5 years SAS programming experience in a clinical trials environment. Candidates must demonstrate thorough knowledge of SAS by successful completion of the SAS core certification test for version 6 SAS (SAS Certified Professional V6) or an equivalent means.  

Susanna ChauSuperGen Investor Relations Managerschau@supergen.com email925-560-2845 tel

SuperGen, Inc.Clinical Research Associate/Sr. CRA"Work for a company that is making a difference in the fight against cancer". SuperGen, Inc. (www.supergen.com) brings together high tech and biotech to search for new, more effective drugs for the treatment of cancer. We are looking for a motivated, dedicated talented team to change the current paradigm of drug discovery and development. This candidate will be working in the Corporate Office

located in Dublin, California – just a 10 minute shuttle ride from the Dublin-Pleasanton BART station.This position will be responsible for management of a global clinical trial. Selected candidate must have experience managing a Contract Research Organization (CRO) and coordinating the work of Regional CRAs.

Partnering with the medical monitor, clinical staff, and other departments, he/she will ensure the clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA).

Designs, plans and implements the overall direction of clinical research projects. Draft and participate in the development of relevant documents for Phase 1 through 3 studies including protocols, informed consents, CRFs, study manuals, monitoring plans, data management plans, abstracts, presentations, and manuscripts and clinical study reports.

Assist in the preparation and finalization of corporate SOPs.

Assist in the preparation of safety, interim and final study reports and resolving data discrepancies.

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Assist in compilation of investigator brochures, under close supervision.

Monitor (able to perform site visits for data collections, source data verification, and review of regulatory documents/files, if applicable) or Co-monitor with CROs, regional monitors as required.

Assist in site selection, study implementation and ongoing management of study sites either directly or via vendor/CROs, if applicable.

Participate in evaluating study drug supply requirements and managing logistics.

Manage CRO/Vendor relationships.

Coordinate and/or participate in Investigator meetings.

Interact with investigators in protocol development, presentations and publications.

Train study coordinators, vendors and investigators regarding Good Clinical Practice/ICH and SuperGen, Inc. processes.

Participate in the development of best practices for Phase 1 through 3 study management.

Requires minimal direction to determine methods and procedures on new assignments.

Travel up to 25%.

Benefits:We provide a comprehensive benefits package to include medical, vision, dental, short and long term disability, group term life, 401(k) and an Employee Assistance Program.

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From: Nikita Manalo [mailto:Nikita.Manalo@onassignment.com]

Sr. R& D Engineer6 month Contract5-10 years of Medical Device experience. Strong Statistical Knowledge,experience with JMP Software, MathCad, and Solidworks. Experience withValidation and Verification of Medical Devices required. Santa Clara___________________________________Quality Engineer - New ProductsContract to Hire

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3-5 Years of Medical Device experience. Strong Quality background desired with the ability to assist with Quality Assurance Support and New Product Development Programs. Validation and Internal/External Audit experiencepreferred. Mountain View___________________________________________Sr. Manufacturing EngineerDirect HireMin 5 Years of manufacturing engineering experience, preferably in a catheter based regulated environment. Experience with Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process FailureMode and Effects Analysis (FMEA) required.Sunnyvale

The following position is through a recruiter. Please respond directly to Danif interested and qualified.

Dan MillerLeading Edge Medical Search, Inc.www.LeadingEdgeMedical.com303.449.9300 Ext. 2

Manager/Director of Electrical EngineeringEssential Duties and Responsibilities include but are not limited to:* Provide continuous engineering support on existing products to maintain and improve margin, performance and quality. * Participate to the development of the product plan and departmental budget. * Manage R&D Managers and Engineers. * Work with General Managers and CTO to assess new product and technology opportunities. * Manage day-to-day activity for R&D Engineering for Instrument groups. * Staffing for product development and process engineering * Manage Electronics and EMI Labs. * Train and develop product development employees * Responsible for Design, Development and Process Engineering of all new electronic products. This activity directly reports to the CTO. * Responsible for overall systems compatibility for all new products that interact with an existing electronic components. * Responsible for Design and Development of Energy Based Devices. This activity reports directly to the General Manager for the Business Unit. Education and/or Experience:Essential. B.S. in electrical engineeringAt least 10 year of experience of technical experience in relevant field (EE in medical device, RF generators, .) and at least 4 years of management experience.Must have knowledge of electrosurgical power supplies. Excellent leadership and motivational skills.

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Desirable: M.S degree or Ph.D. in related technical area. Experience in Electrosurgical RF generator design and electrosurgical devices.

. If you meet therequirements, please contact Abhishek Banerjee @ abanerjee@saccinc.com .PROJECT MANAGER -APL – REGULATORY, AffymetrixRequisition #: 3578

This position is key to driving execution on Affymetrix's product development efforts. Project managers will work within Affymetrix’s established phase gate product development process, typically as Core Team Leaders, to drive projects to meet schedule, quality, COGs, product feature, and cost deliverables. Successful candidates must be capable of working collaboratively with project “Core Team” members from various functions (particularly Product Marketing and Development leads) to successfully drive new product concepts to market under extremely aggressive timelines in a dynamically evolving technology environment. Many of the applicable programs have complex system integration elements, so comfort with integrated systems is required.

Key responsibilities:As Core Team Leader, the candidate will be accountable for execution on project timelines and overall program goals from initial concept through successful commercialization. The Core Team Leader drives general project management including:• Development of project contract including project schedule and deliverables.• Analysis of project risks and maintenance of project schedule.• Schedule and chair Core Team meetings.• Ensure all aspects of project are covered, assign project deliverables.• Prepare meeting agendas, publish meeting minutes, ensure all required project documentation is generated and archived (including but not limited to project definition, project plans, risk analysis, financial analysis, market analysis, technical documentation, monthly progress reports, presentations, technical reviews, organization readiness reviews, etc.)• Primary liaison between all teams and departments involved in the product development/delivery process to resolve issues, facilitate tradeoff decisions, and remove obstacles. The Core Team Leader plays a key role in identifying and resolving or escalating resource conflicts/gaps.• Collaboration with project Core Team Members (particularly Product Marketing and Product Development team leads) to prepare and present phase-based project approval review materials to senior management on Affymetrix’s Product Approval Committee (PAC).• Analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.• Responsible for compliance of project records with appropriate regulatory guidelines.• Interfacing with internal and external regulatory compliance groups for project audits, both pre- and post-product launch.

Position Requirements

• Bachelor's (B.S./B.A.) or advanced degree, preferably in a scientific/technical discipline (biology,

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molecular biology, chemistry, etc.).• Documented and certified QSR, GMP/GLP or other regulatory training.• Direct experience with managing assay, reagent, instrument or software development projects directed at regulated products.• Minimum of 5 years of experience combined between program/project management and product development and commercialization, preferably in a life sciences/biotechnical industry. • Project management skills – experience in successfully managing large and small multi-disciplinary team projects using standard project management tools. • Knowledge of standard product development cycle (theoretical) and the actual process (practical application).• Experience with the Core Team Model and as a Core Team member.

If you meet these requirements, please contact  reza islam [ rezadeshi@yahoo.com

1.

If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .

Sr. Quality Associate—CV Therapeutics

 

A Bachelor’s degree in the sciences (biology, chemistry, analytical, bio-analytical chemistry, or chemical engineering) with a minimum of 7 years of pharmaceutical experience in a GMP quality (QA/QC) environment. Good working knowledge of Quality Systems and GMP standards. Knowledge of European regulations is desirable. Detail-oriented with excellent review skills of product records for lot disposition. Problem solving and analytical skills as well as technical writing abilities. Ability to reconcile more complex issues independently. Ability to organize and manage multiple tasks in a fast-paced environment. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e. Microsoft Office products).

 

This position is to provide quality assurance support for CVT’s commercial and clinical programs.

• Review and approve master batch records, labels, product specifications and other pre-production documents for compliance to FDA and international health agency requirements.

• Review executed production batch records and analytical data related to lot release and associated documentation including any deviation and investigation reports.

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• Review and approve stability protocols, data packets and study reports • Maintenance of electronic databases (Scientek) and paper archives (lot history records, reports, logbooks).

• Write, revise and review standard operating procedures.

• Review product development reports, protocols and labels.

• May review and approve validation protocols and final reports.

• Interact with contractors to resolve lot release or validation issues.

• Assist in review of CMC sections of regulatory submissions.

• Up to 20% of travel may be required.

If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .

Mgr, Regulatory Affairs

Emeryville, CA--Novartis

Plan and coordinate the preparation (and assist in the preparation, as necessary) and maintenance of regulatory submissions for U.S. and product registrations to applicable foreign regulatory bodies. Specifically, the duties will include management of various types of regulatory submissions: Biologics License Applications (BLA) and related Supplements and Amendments, Investigational New Drug Applications (IND), Export Applications, as appropriate by product and regulatory strategy and ex-US product registrations.

In addition, this position will include direct involvement at the project team level in order to provide regulatory support for new product development and existing product lines.

May have direct supervision of one or more Regulatory Associates as appropriate by project category. A minimum of a BA/BS in the biological sciences (with an emphasis on molecular biology, biochemistry, immunology, or related field). Advanced degree desirable.

The ideal candidate should have at least 5 years direct relevant experience in a FDA-regulated environment including direct experience with in vitro diagnostic (IVD) products - regulated as biologics (FDA/CBER) or medical devices (FDA/CDRH). Knowledge of cGMP, QA/QC principles, and Quality Systems is also desired.

Prior experience with computers (e.g., word processing and spreadsheets) is highly desirable. The candidate should possess very strong written, verbal, and interpersonal communication skills. Ability to work both independently as well as in close collaboration with multidisciplinary teams will be required. The RA Manger will report to a Director of Regulatory Affairs.

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The RA Mgr. Should have an understanding of the underlying regulatory strategy and background as related to as specific project. In addition, an adeptness and desire for problem solving and decision making in a cross-functional team setting are essential characteristics.

The RA Mgr. must assume a lead role in the completion of projects, must be able to organize and prioritize work assignments, effectively manage time and available resources and work independently and closely with individuals of various responsibilities and educational levels throughout the company. The RA Mgr. must consider the overall impact of decisions as they affect other aspects of the business and will initiate appropriate actions as required.

The position is a day shift position and will be based at the Chiron headquarters facility in Emeryville, CA

EOE Minimum Education Required Bachelors Minimum Experience Required 5-8 Years

If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .

Assoc Dir, Quality Operations

Location: Emeryville, CA

Job Description

Located at our global headquarters in Emeryville, California, Novartis Diagnostics is constantly finding revolutionary ways to protect the blood supply, and diagnose and monitor patients.

Novartis Diagnostics is actively transforming the landscape of disease prevention, diagnosis, and treatment with state-of-the-art nucleic acid testing and advanced molecular science. As part of Novartis Corporation, which has operations in 140 countries and on 5 continents; we provide a truly global environment. This means you will have more opportunities to advance your career and to make a real impact around the world.

Reporting to the VP, Quality Operations, the Associate Director, Quality Operations role will support global expansion activities to ensure quality procedures and infrastructure are in place to support commercial activities in compliance with Novartis quality standards. Additionally the position will be responsible for coordinating the Diagnostics Quality Improvement Projects (QIP) and Innovation, Quality, Productivity (IQP) activities, ensuring effective implementation of quality improvement initiatives globally.

Primary Responsibilities:

  Attend Diagnostics Commercial Committee meetings and coordinate efforts for regional

expansion.

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Coordinate quality activities between the regional offices, commercial operations, global marketing and the Diagnostics Quality Headquarters in Emeryville to support timely implementation of quality requirements.

Support regional quality heads with Quality Manual implementation and mitigation of quality improvement remediation plans

Contribute to Material Review Committee (MRC) meetings to facilitate Third-Party supplier reviews, remediation and approval

Coordinate Diagnostics QIP global activities. Attend QIP and Bluechip team meetings, track commitments and timelines to ensure QIP

implementation as planned Coordinate QIP and IQP initiatives with regional Quality heads High level of impact on the Diagnostics business based on geographic expansion planning and

ensuring the delivery of quality products. Supports our commitment to quality improvement and is highly visible throughout the division to coordinate our compliance with quality improvement initiatives.

Minimum requirements: Bachelor’s degree in Biological Sciences, Quality Management or related field.

QIAS or QCPA, LEAN Six-Sigma desirable Fluent English (oral and written) required with

Spanish and/or Mandarin (oral) a plus. 10+ years management experience in Quality operations in biotechnology, preferably blood

banking, diagnostics, medical device or bio-pharmaceutical industries. Experience in a regulated GMP manufacturing environment is required. Strong analytical and written skills, proficient in MS Word and MS Excel software In depth knowledge of FDA, ex-USA and ISO regulation requirements as well as standard

Quality management tools and standards. Experience working with FDA licensed biologics including FDA inspections. Must have good planning and organizing skills, manage time effectively by prioritizing tasks,

taking the initiative to solve problems quickly, and knowing when to obtain assistance. Individual must work in an ethical manner and ensure regulatory and Novartis Quality System

requirements are followed. Experience with LEAN Six-Sigma; black-belt preferred The position requires a strong understanding of global quality system regulations. Demonstrated experience leading quality improvement teams to successful measurable

outcomes is required. Strong leadership skills and experience in leading diverse teams that are not direct reports Strong organization skills, with the ability to prioritize and get projects completed on-time Excellent written communication and report writing skills;

Strong cGMP background.

Minimum Education Required-Bachelors

Minimum Experience Required 8-15 Years

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If interested and you meet the requirements, please send your resume to Abhishek Banerjee at abanerjee@saccinc.com .

Sr Manager, Quality Assurance

 Palo Alto

Job Description: OUR CLIENT seeks  a Senior Manager of Quality Assurance. This position is responsible for the management and maintenance of OUR CLIENT’s external and internal audit programs.

 

DUTIES AND RESPONSIBILITIES:

• Manage the cGMP vendor qualification program; apply risk based methodology to conduct and coordinate cGMP audits of contract manufacturers, testing laboratories, packagers and distribution centers

• Manage and conduct both internal and external cGMP audits as a lead auditor.

• Prepare audit agenda, execute audits and issue audit reports

• Perform training needs assessment based on audit trends

• Manage the CAPA program and conduct effectiveness assessments

• Support the development and maintenance of quality systems such as Change Control and Deviations

• Review and revise SOPs for consistency and compliance with regulatory requirements

• Support regulatory inspections by FDA and foreign regulatory agencies

Qualifications:

• BS/BA in a scientific discipline and a minimum of 10 years of pharmaceutical experience

• Must have a minimum of 5 years of direct experience and strong auditing skills in conducting and leading cGMP audits of API, bulk drug product, packaging facilities, distribution centers and testing laboratories

• Must have strong working knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks

• Experience with small molecule drugs

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• Excellent communication skills (both oral and written) and the ability to work collaboratively across departments

• Strong attention to detail

• ASQ or equivalent certification is highly desirable

• Ability to travel up to 35%

OUR CLIENT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan.

 

******************************************************************************

 

Jobs That Crossed My Desk, Feb. 1-9, 2009

For more information on Philips careers please visithttp://www.philips.com/careersThanks for your interest in new job opportunities at Philips.  There arecurrently job(s) that were found to match your interests, AND we hopeyou'll click on the links below for more information on some of them.Remember, you can submit your resume online, AND if your qualificationsare suited for current openings, a member of our staffing organizationwill contact you.

  Search Agent: Marketing Product Manager  Total Hits: 1

    Job Title:  Senior Program Manager / Product Development    Job ID:  57421    Job Details Link:http://careers.peopleclick.com/careerscp/client_philips/external/en-us/gateway.do?functionName=viewFromLink&jobPostId=192964&localeCode=en-us&email=true

If you decide you don't want to receive these emails any more, you canupdate your preferences in Your Profile.********************************************************************************Here’s a new website dedicated to life science recruiting with listings in various sectors of our industry. Go to BeakerBeat.com and see if this site is helpful.

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BeakerBeat, has a weekly video webcast of everything life sciences; and claims 11,000 open positions and 200 video-enabled company profiles on their Beaker.com site.

And another new website which includes jobs but also a virtual exhibit hall for companies—this one is dedicated to pharma entitled PharmaExpo.com at http://www.epharmaexpo.com/job.php

*********************************************************************************

International Career Fair 2009, Friday and Saturday, Feb. 20-21, 2009

Date and Time: Friday, February 20 and Saturday, February 21, 2009 Location: Cathedral Hill Hotel, 1101 Van Ness Avenue, San Francisco, California, DirectionsRegister: Register and upload your resume at www.icf09.com. It's quick and easy, and it's FREE! See details at http://www.icf09.com/jsp/core/PlageHome.jsp

Go to http://www.icf09.com/jsp/core/PlageHome.jsp to Register

*********************************************************************************

Biotech Beach Career Fair, Monday Afternoon, Feb. 23, 2009

Event: Biotech Beach Career FairDate and Time: Monday, February 23, 2009, 1pm to 6pmLocation: San Diego Marriott - La Jolla, La Jolla, California

Event Description

Do not miss the chance to interview with the biopharmaceutical industry's most prestigious companies! All candidates must have at least a four-year college degree and two years of industry related work experience to attend. (Equivalent work experience may be considered in lieu of a four-year college degree.)

Qualified candidates will receive their invitations and confirmation numbers via email no later than 72 hours prior to the career fair. Pre-screened and accepted candidates must bring a copy of their invitation with confirmation number to the event.

Preregister at: http://www.biospace.com/jobs/career-fair-detail/?CareerFairId=164&source=1386

Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Southern California region.

Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, bioinformatics, chemistry, marketing, regulatory affairs, and research.

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What companies will be there?Scroll to the bottom of the pages to see a list of exhibiting companies. Take the time to research what each company is recruiting for to see if you are a match. Most companies will be from the Southern California region, but some will travel from other areas to attract top talent! If you can’t make it on event day, you can still pre-register online to allow exhibiting companies to view your resume and contact you outside of the career fair.!

BioSpace Career Fair Teamcontactus@biospace.com

The South San Francisco Life Science Career Fair, Monday, March 9, 2009

Date and Time: March 9, 2009, 10 am to 4 pmLocation: South San Francisco Conference Center

The Career Fair is an opportunity for displaced biotech employees or life science students to meet company and industry professionalsThe life science industry offers jobs for all education and skill levels. Over 25 life science companies will be available to meet with youIn addition to looking for a job, visit our Wellness Room to learn how to take care of yourself in these economic times

Meet your local Workforce Board representatives who can provide you with resources and support you in your job search. Meet your Professional Organization for extensive networking opportunities.Get one-on-one resume review and advice (sign up on-site)Learn how to center and focus in times of stress (sign up on-site)Thinking of starting your own business, meet our Incubators

For further information, please contact us at ssfcareerfair@gmail.comPlease register by Friday, February 27, 2009.To Pre-Registration, go to http://tinyurl.com/d5eha9*******************************************************************************

These job postings are listed on my blog accessed at www.audreysnetwork.com along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly.

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