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

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.

Responsibilities

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; Leads the cross-functional Clinical Development Team in the design, execution and interpretation of studies in support of worldwide regulatory submissions; Creates and gains endorsement for the Clinical Development Plan and associated protocol design documents; Partners with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget; Develops comprehensive clinical development plan to secure approval and reimbursement globally; Leads efforts on regulatory submissions and contributes to submission deliverables; Provides product/program specific input for target product profiles; Develops specific clinical development enabling strategies including digital/innovation and patient engagement approaches; Partners with Trial clinicians on governance reviews; Provides therapy area/indication expertise in support of clinical review of clinical data; Provides specialized medical monitoring support for individual trial team; Key partner in trial-level statistical analysis plan, table-listings-figures, database release; Develops submission level deliverables; Supports appropriate interpretation and communication of clinical trial data; Reviews and approves submission level safety narrative plan; Supports product label development and maintenance; Engages key external stakeholders; Provides regulatory submission support (DSUR, PBRER); Ensures compliance with internal SOPs and external regulatory standards; Reviews IIR proposals

Requirements

MD or DO; 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; Medical/Scientific credibility/Excellence; Management experience in a highly complex matrixed environment; Leadership; Influencing; Conflict Management; Team Building; Accountability; Change agile; Breadth of diverse leadership experiences; Candidates must be authorized to be employed in the U.S. by any employer; U.S. work visa sponsorship is not available for this role now or in the future; This position requires permanent work authorization in the United States

Nice to have

Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs; Demonstrated experience in designing and launching large teams preferred

Benefits

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary; Share based long term incentive program; 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution; Paid vacation, holiday and personal days; Paid caregiver/parental and medical leave; Health benefits including medical, prescription drug, dental and vision coverage; Relocation support available