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

Role Summary 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 throughout 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. They may assume responsibility for other clinical leadership opportunities in support of the Obesity portfolio, including trial design, execution and reporting of clinical trials for other late-stage assets in the portfolio. In addition, this leader: May provide specialized monitoring support if required Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview Provide input for target product profile(s) and regulatory activities such as product labels, core data sheets, Investigator Brochures, Development Safety Update Reports and Periodic Benefit‑Risk Evaluation Reports Responsibilities 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 Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) and for creating the pediatric investigation plan / pediatric study plan and associated protocol design documents, working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution Provide product/program specific input for target product profile(s) Show willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies Develop specific clinical development enabling strategies, including digital/innovation and patient engagement approaches Partner with Trial clinicians on governance reviews (incl Sci/Ops) for assigned clinical studies and provide category-specific clinical development strategy input and insights to trial clinicians Provide therapy area/indication expertise in support of clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events as required Provide 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 Develop submission‑level deliverables (IAP, IARP and submission TLFs). Responsible for submission deliverables including SCE and SCS Support appropriate 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 – e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates – to drive strategic insight generation to support clinical development strategy and PDD development Provide regulatory submission support – DSUR, PBRER submission disclosures and product defense Ensure compliance with internal SOPs and external regulatory standards Review IIR proposals Basic Qualifications MD or DO Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs 8+ years of relevant experience and a 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 in relating to individuals both inside and outside Pfizer Demonstrated experience managing and training large teams in clinical development Demonstrated experience in designing and launching large teams preferred Competency Requirements Medical / Scientific credibility/Excellence – Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy; demonstrates understanding of complexities and recent developments in the principal disease areas, and is comfortable discussing scientific/mechanistic aspects of drug development along with commercial and regulatory issues Management experience – Able to work in a highly complex matrixed environment and influence cross‑functional teams Leadership – Persuasive and effective leader of staff Influencing – Able to manage and motivate internal teams on clinical trials Conflict Management – Mentor/coach to others to improve conflict management skills; steps up to conflicts, view them as opportunities, resolve tough agreements and settle disputes equitably; prepared to take responsibility for a decision and support it, even if unpopular Team Building – Shares wins and success, fosters open dialogue, lets people finish and be responsible for their work, defines success in terms of the whole team, creates strong morale and spirit in the team, creates a feeling of belonging Accountability – Take personal responsibility for results, pushing self and others to exceed goals and deliver results Change agility – Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amid organizational change 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 Non‑Standard Work Schedule, Travel or Environment Requirements Up to 30% travel may be required. Relocation support available. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week. Compensation and Benefits The annual base salary for this position ranges from $274,500.00 to $457,500.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share‑based long‑term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.* The annual base salary for this position in Tampa, FL ranges from $228,700.00 to $381,100.00. This role is posted in multiple locations. If you are applying for the role in a secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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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. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. 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