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Group Leader, Clinical Assay

Job Title
Group Leader, Clinical Assay

Job Description

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
• Responsible for execution of clinical pharmacology small molecule bioanalytical support including method development, validation, life cycle management, outsourcing, vendor oversight in support of the Pfizer’s clinical portfolio from First in Human through Loss of Exclusivity.

• Serve as a resource to support clinical pharmacology work across Disease Areas (DAs).

• Oversight of pharmacokinetic (PK) and biomarker (BM) assay programs at external contract research organizations (CRO’s) and in house PK and BM assay laboratories, as appropriate.

Responsibilities
• Lead and manage the small molecule discipline team within the Clinical Assay Group to ensure optimal support across projects and DAs.

• Manage Clinical Assay Group resources in conjunction with Head of Clinical Assay and other Group Leaders.

• Member of Clinical Assay Group Leadership Team.

• Hire, coach, mentor and develop Clinical Assay Specialists.

• Develop standards and best practices for the Clinical Assay Group that promote cost-effectiveness, efficiency and quality which are consistent with internal and regulatory expectations.

• Support the Head of Clinical Assay, as appropriate, in formulating global Clinical Assay Group Policies, including those for standards.

• Identify, negotiate with and manage relationships with various external clinical assay vendors.

• Keep current on latest technology developments and ensure appropriate adoption of new applications with potential to improve drug development.

• Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure that Pfizer bioanalytical practices are consistent with regulatory expectations.

• Oversight of clinical PK and BM assays run internally and at external CROs. Act as point of contact for Clinical Assay Group for those externals CROs.

• Serve as Assay representative on Study teams to ensure effective management and organization of the delivery of PK and BM assays for those studies and projects.

• Method development and validation of new assays, and transfer and validation of developed assay methods to external CROs. Lead troubleshooting the methods when this technology transfer encounters difficulties.

• Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory and Industry standards and that data are of the required quality (regulatory and scientific).

• Periodically inspect external CROs performing assays that support Pfizer programs.

• Assist in writing regulatory submissions and responds to regulatory queries when needed.

• Ability to produce and present quality scientific papers at external meetings and for publication.

Qualifications
Training & Education Required:
• BS with extensive post-graduate training/experience in the use/application of bioanalytical methods (PK, ADA, BM) to support clinical pharmacology studies and clinical drug development.

Training & Education Preferred:
• MS or doctoral degree with extensive postgraduate training/experience in the use/application of bioanalytical methods (PK, ADA, BM to support clinical pharmacology studies and clinical drug development.

Prior Experience Required:
• Very extensive experience in working with bioanalytical laboratories that support assays (PK, ADA, BM) for clinical pharmacology studies in drug development.

• Extensive experience in managing clinical assay specialists, including resource management, staff development, handling multiple projects.

• Very good understanding of bioanalytical methodologies, regulatory and scientific standards.

• Demonstrated record of leadership (inspires others to achieve or exceed goals).

• Good understanding of clinical drug development and clinical pharmacology.

Technical Competencies Required:

Skills Management
• Demonstrated ability to manage complex projects and cross-functional teams.
• Experience and ability to manage performance and development of a large group of people.
• Demonstrated success/ results in prior scientific management roles.
• Ability to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors.
• Understanding of bioanalytical methods used to support clinical pharmacology studies and the scientific/ regulatory standards for method validation, quality control, etc.
• Applies current thinking on latest technology developments to ensure appropriate adoption of new applications with potential to improve drug development.

Scientific Excellence
• Able to pragmatically apply technology to meaningfully impact drug development effort.

Business acumen
• Able to identify, negotiate, and manage relationships with various external clinical assay vendors.

Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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Desired Skills and Expertise
Bachelor's Degree

Industry
Other

Experience
2 - 5 years

Job Type
Full Time

Salary / package
Not Specified

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