Global Development Lead, Internal Medicine, Sr. Director (MD)

The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. The individual will lead the cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues in the design, execution and interpretation of studies in support of worldwide regulatory submissions. The individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents. The GDL is a key partner for other clinical and clinical operations colleagues through the lifecycle of all studies for the assigned asset(s). The GDL may also act as a key partner to external companies in support of Pfizer’s Partner of Choice model. The individual is expected to be an internal subject matter expert in their therapeutic area and in clinical drug development.

Responsibilities

Lead the cross-functional Clinical Development Team in design, execution and interpretation of studies in support of worldwide regulatory submissions; Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; Lead efforts on regulatory submissions and contribute to submission deliverables including SCE, SCS and clinical overview; Partner effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget; Develop comprehensive clinical development plan to secure approval and reimbursement globally including China and Japan, and create pediatric investigation plan/study plan; Provide product/program specific input for target product profile(s); Develop specific clinical development enabling strategies including digital/innovation and patient engagement approaches; Partner with trial clinicians on governance reviews for assigned clinical studies; Provide therapy area/indication expertise in support of clinical review of clinical data including CRF design, signal interpretation, and contextualizing adverse events; Provide specialized medical monitoring support for individual trial teams if required; Partner in trial-level statistical analysis plan, table-listings-figures, and database release; Develop submission level deliverables including IAP, IARP and submission TLFs; Support interpretation and communication of clinical trial data; Review and approve submission-level safety narrative plan; Support product label development and maintenance; Engage key external stakeholders including Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates; Provide regulatory submission support including DSUR and PBRER; Ensure compliance with internal SOPs and external regulatory standards; Review IIR proposals

Requirements

MD or DO; Background in chronic weight management, endocrinology or internal medicine with experience in Phase 1-3 clinical development and translational medicine; 8+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development; Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management; Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills; Demonstrated experience managing and training large teams in clinical development; 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; Permanent work authorization in the United States

Nice to have

Demonstrated experience in designing and launching large teams preferred

Benefits

25.0% bonus target of base salary; share-based long term incentive program; 401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contribution; paid vacation, holiday and personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental and vision coverage; relocation assistance may be available