9 days old

Clin Pharm Group Head Internal Medicine

Cambridge, MA 02139
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Responsible for:

+ Clinical pharmacology components of in-scope projects (both directly and indirectly)

+ May act as Clinical Pharmacology Lead on clinical sub-team and development team as appropriate.

+ Responsible for providing the clinical pharmacology components of clinical plans and provide clinical pharmacology expertise to the project team.

+ Have an intimate understanding of the overall clinical development plan and work closely with the clinical and development teams to continually update and refine plan.

+ With Clinical Lead, assure that assigned clinical pharmacology study(ies) fulfills its role in the overall development plan.

+ Plan, design and manage clinical pharmacology studies as required with operational/clinical assistance from clinical research operations/clinical as required. Accountable and responsible for assigned study outline, core protocol elements and study report content, where appropriate.

+ With study team, track emerging clinical pharmacology profile of the drug, keep line management informed of changes in the profile as they occur in the assigned study(ies).

+ Fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.

+ Collaborates with other team members and the medical writer in the data review, analysis and reporting of the clinical pharmacology study and clinical pharmacology components of efficacy/safety trials. In conjunction with medical writer is responsible for overall content and accuracy of the clinical pharmacology study report before forwarding for final sign-off. Assist with internal and external dissemination of results to development team, investigators etc.

+ Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, exposure-response analysis, meta-analysis etc. Direct the planning of all relevant PK-PD analyses.

+ Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with quantitative systems pharmacology, pharmacometrics and statistics (as relevant).

+ Provide recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, etc.) to the clinical and development teams and in regulatory documentation.

+ Collaborates with preclinical and QSP colleagues in building mechanistic understanding of target/disease to increase confidence in target engagement and validation

+ Lead clinical pharmacology contributions to all regulatory documents including IND, Investigator's Brochures, End of Phase 2 meetings etc. Lead the resolution of clinical pharmacology queries from drug regulatory agencies; take a lead role in writing and reviewing responses to regulatory queries.

+ Accountable for ensuring that there are valid methods for measuring drug concentration and anti-drug antibodies (where appropriate) for clinical studies

+ Accountable for quantitative aspects of translational pharmacology, and help champion the discipline

+ Management and career development for direct reports

+ Responsible for resourcing, recruitment, supervising, training, motivating and developing colleagues in clin pharm lead activities

+ Coach and mentor the clinical pharmacology organization

+ Provides strategic leadership to clinical pharmacology activities.

+ Ensures that the support network e.g. Pharmacometrics, Clinical Assay Group, Clinical Research Operations is operating effectively for clinical pharmacology staff.

+ With ECD Clinical Pharmacology Head, optimal use of clinical pharmacology resources across WRD portfolio in scope

+ Allocates resources appropriately to ensure clinical pharmacology project activities are completed within allocated therapeutic area

+ Using business and colleague development rationale, ensure Cambridge WRD portfolio is appropriately resourced [the expectation is 30% work will be non-TA aligned]

+ Ensure cross-RU learnings through proactive engagement and training

+ May act as a Clinician or Project Lead for specific drug development projects.

+ May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.

+ Application, development and advancement of Pfizer-wide clinical pharmacology best practices and overall support of Pfizer-wide clinical pharmacology community

+ Provide resources (as appropriate) to author/update Pfizer Global Clinical Pharmacology Guidance documents and other similar initiatives

+ Ensure Clin pharm plans, studies and analyses are performed to the appropriate standards

+ Proactively improve efficiencies in early clinical development clinical pharmacology and across the ECD organization

+ With statistics and clinical colleagues, ensuring appropriate application of data-driven approaches to clinical studies and plans

+ Ensures appropriate methodologies, datasets and approaches are used in study design and analyses

+ Provides leadership in efficiency, automation and innovation in early clinical programs

+ Champions the EQD3 Forum, EQDD sub-teams and other similar cross-discipline quantitative teams in support of projects

+ Provides leadership in disease-driven approaches, including disease modelling /systems pharmacology approaches, natural history datasets, model based meta analysis as appropriate

+ Clin pharm leadership, both internally (e.g. appropriate governance bodies) and externally (e.g. professional societies, publications, presentations).

+ Represents clinical pharmacology on appropriate governance bodies, eg CPSDC, PRC, TRC etc.

+ Provides strategic/scientific input to discovery/PDM/BMD on clinical pharmacology issues.

+ Provides input to strategy as part of RU leadership where possible

+ Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.

+ Represents Pfizer on appropriate external professional bodies, working groups etc. that advance the discipline of clinical pharmacology

+ Supports and leads publications based on Pfizer programs and/or clinical pharmacology methods/advances

+ Encourages appropriate external collaborations that support disease/project goals


**"Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve** **meaningful outcomes and create business impact."**

+ Education: Ph.D. or equivalent training or experience in clinical pharmacology, pharmacometrics, pharmacokinetics, engineering or related discipline.

+ Demonstrated experience with clinical pharmacology aspects of drug development (will vary for each position) with 10+ years of experience

+ Clinical pharmacology: demonstrates thorough understanding of the following: 1) principles of PK, PK-PD (including population and mechanistic approaches) and pharmacology relevant to drug candidates; 2) knowledge of phase I studies including design conduct and interpretation; and 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics.

+ Communication Skills: demonstrates ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise; proven history of influencing teams and leaders.

+ Scientific Excellence: demonstrates understanding of the complexities and recent developments in clinical pharmacology and the implications for drug development.

+ Regulatory Knowledge: understands and is able to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies.

+ Management Experience: experience of management of advanced degree (e.g. PhD) level colleagues with clear history of providing appropriate feedback, colleague development and colleague empowerment

**Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

+ \#LI-PFE

Relocation support available

**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.

**EEO & Employment Eligibility**

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.

Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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Clin Pharm Group Head Internal Medicine

Cambridge, MA 02139

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