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. 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 lifestyle 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. They may assume responsibility for other clinical leadership opportunities in support of the Obesity portfolio. This may include responsibilities for trial design, execution and reporting of clinical trials for other late-stage assets in the portfolio.

Responsibilities

Partners effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget; Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents; Provides product/program specific input for target product profile(s); Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies; 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, if required; Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programming; Develops submission level deliverables (IAP, IARP and submission TLFs), responsible for SCE and SCS; Support appropriate interpretation and communication of clinical trial data; Review and approve submission level safety narrative plan; Supports product label development and maintenance; Engage key external stakeholders to drive strategic insight generation; Provides regulatory submission support (DSUR, PBRER) and product defense; Ensures compliance with internal SOPs and external regulatory standards; Review IIR proposals

Requirements

MD or DO; Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience including type 2 diabetes experience; 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; Candidates must be authorized to be employed in the U.S. by any employer; U.S. work visa sponsorship not available for this role; Requires permanent work authorization in the United States; Up to 30% travel may be required; This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week; Medical / Scientific credibility and excellence; Management experience in a highly complex matrixed environment; Leadership; Influencing; Conflict Management; Team Building; Accountability; Change agile; Diverse leadership experiences including ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues

Nice to have

Demonstrated experience in designing and launching large teams preferred

Benefits

Participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of base salary; Share-based long term incentive program; 401(k) plan with Pfizer Matching Contributions; 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