Global Development Lead Senior Director - Internal Medicine, MD
$228.7k - $457.5k/yr
Expert
MD
Cambridge, MA, USA+9 moreMore locations: Collegeville, PA, USA | Kirkland, QC, Canada | Lake Forest, IL, USA | Tampa, FL, USA | Bothell, WA, USA | Pearl River, NY, USA | La Jolla, San Diego, CA, USA | Groton, CT, USA | New York, NY, USA
HybridHybrid: on-site an average of 2.5 days per week; must live within commuting distance. Up to 30% travel. Relocation support may be available.
Biology & Biotech
No H1B Sponsorship
About the job
Requirements
- An MD or DO is required.
- A cardiologist with cardiovascular outcome trial experience or experience in large, complex global development programs is strongly preferred.
- At least 8 years of relevant experience and a track record of success in academia and/or the biopharmaceutical industry in clinical research and development are required.
- Extensive knowledge of clinical development, global and regional regulation, International Council for Harmonisation/Good Clinical Practice (ICH/GCP), and adverse-event management is required.
- Demonstrated clinical/medical, administrative, and project-management capabilities are required.
- Experience managing and training large teams in clinical development is required.
- Experience designing and launching large teams is preferred.
- A track record of achievement in pharmaceutical development and the ability to coordinate and execute clinical development or lifecycle strategy are required.
- Understanding of the complexities and recent developments in the principal disease areas, including the ability to discuss scientific and mechanistic aspects of drug development and commercial and regulatory issues, is required.
- Management experience working in a highly complex matrixed environment and influencing cross-functional teams is required.
- Leadership skills to lead staff effectively are required.
- The ability to manage and motivate internal clinical-trial teams is required.
- The ability to mentor and coach others in conflict management, address conflicts, negotiate difficult agreements, settle disputes equitably, and take responsibility for decisions is required.
- The ability to foster open dialogue, shared success, team accountability, and strong team cohesion is required.
- The ability to take personal responsibility for results and help exceed goals is required.
- The ability to maintain perspective and effectiveness amid uncertainty and organizational change is required.
- A breadth of diverse leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues' work to achieve outcomes and business impact, is required.
- Candidates must be authorized to work in the United States by any employer and have permanent work authorization in the United States.
- Candidates must live within commuting distance of the assigned work location and work on-site an average of 2.5 days per week.
Responsibilities
- Represent Clinical on the Global Medicine Team and serve as the single clinical point of accountability for clinical development of assigned assets in Internal Medicine.
- Lead the cross-functional Clinical Development Team, including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues, in designing, executing, and interpreting studies supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol-design documents.
- Partner with clinical and clinical-operations colleagues throughout the lifecycle of studies for assigned assets and may partner with external companies.
- Act as an internal subject-matter expert in the therapeutic area and clinical drug development.
- Take on other clinical leadership responsibilities in support of the Obesity portfolio, including trial design, execution, and reporting for other late-stage portfolio assets.
- Provide specialized monitoring support when required.
- Lead regulatory-submission efforts and contribute submission deliverables, including the SCE, SCS, and clinical overview.
- Provide input on target product profiles and regulatory activities, including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.
- Partner with the Medicine Team Lead to negotiate tradeoffs and milestones and deliver the clinical program within agreed timelines and budget.
- Develop a comprehensive clinical development plan to secure global approval and reimbursement, including in China and Japan, and create the pediatric investigation plan or pediatric study plan and related protocol-design documents with trial clinicians to ensure feasibility and optimized execution.
- Provide product- and program-specific input for target product profiles.
- Develop enabling strategies for clinical development, including digital innovation and patient-engagement approaches.
- Partner with trial clinicians on governance reviews and provide clinical-development strategy input and insights for assigned studies.
- Provide therapeutic-area and indication expertise in clinical review of data, including case report form design, signal interpretation, and contextualization of adverse events.
- Provide specialized medical-monitoring support to individual trial teams when required.
- Partner with statistics and programming on trial-level statistical analysis plans, tables, listings, figures, and database release.
- Develop submission-level deliverables, including IAP, IARP, and submission tables, listings, and figures; take responsibility for submission deliverables including SCE and SCS.
- Support appropriate interpretation and communication of clinical-trial data.
- Review and approve submission-level safety narrative plans.
- Support product-label development and maintenance.
- Engage external stakeholders, including advisory boards, steering committees, data monitoring committees, adjudication committees, patients, and patient advocates, to generate strategic insights supporting clinical-development strategy and product development and delivery.
- Provide regulatory-submission support, including Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, submission-disclosure deliverables, and product defense.
- Ensure compliance with internal standard operating procedures and external regulatory standards.
- Review investigator-initiated research proposals.
- Travel up to 30% as required.
Desired Qualifications
- Demonstrated experience designing and launching large teams is preferred.
About the company
Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.
Company Size
10,001+
Company Stage
IPO
Headquarters
New York City, New York
Founded
1849
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Simplify's Take
What believers are saying
- Newer drugs carry the business: launched and acquired products grew 18% operationally in Pfizer's August 2026 quarterly report.
- The outlook improved: in August 2026, Pfizer raised its 2026 revenue guidance to $60.5 billion to $62.5 billion.
- Vaccine scientists get room to grow: Pfizer's $470 million Pearl River, New York research expansion is designed for 370 workers.
What critics are saying
- Expect more site cuts: in November 2025, Pfizer moved to shrink Swiss staff from about 300 to roughly 70.
- Generics will erase sales: Pfizer expects patent losses to cut $17 billion to $18 billion of yearly revenue through 2028.
- Pfizer is chasing obesity leaders: Metsera's monthly shot showed 12.3% weight loss at 28 weeks in February 2026 data.
What makes Pfizer unique
- Pfizer bought its way into cancer: its Seagen buyout added antibody-drug conjugates, which carry chemotherapy straight to tumors.
- Pfizer is betting on monthly obesity shots: Metsera's berobenatide is dosed once a month, unlike weekly Wegovy and Zepbound.
- Pfizer leans on one partnered heart drug: blood thinner Eliquis, sold with Bristol Myers Squibb, brings about 14% of revenue.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Retirement Plan
- 401(k) Company Match
- Paid Vacation
- Paid Sick Leave
- Paid Holidays
- Hybrid Work Options
- Relocation Assistance