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Pfizer

Makes cancer drugs, vaccines and other medicines

Global Development Lead Senior Director - Internal Medicine

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$228.7k - $457.5k /yr

About the Job

Requirements

  • MD or DO.
  • Be an endocrinologist or internal medicine physician with cardiometabolic late-stage development experience, including type 2 diabetes experience.
  • Have 8 or more years of relevant experience and a track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
  • Have extensive knowledge of clinical development, global and regional regulation, International Council for Harmonisation Good Clinical Practice, and adverse event management.
  • Demonstrate clinical/medical, administrative, and project management capabilities, along with effective verbal and written communication skills when relating to individuals inside and outside Pfizer.
  • Demonstrate experience managing and training large teams in clinical development.
  • Demonstrate medical/scientific credibility and excellence, including a track record of achievement in pharmaceutical development and the ability to coordinate and execute clinical development or lifecycle strategy.
  • Demonstrate understanding of complexities and recent developments in principal disease areas; confidently discuss scientific and mechanistic aspects of drug development and commercial and regulatory issues.
  • Be able to work in a highly complex matrixed environment and influence cross-functional teams.
  • Demonstrate leadership, including persuasive and effective leadership of staff.
  • Be able to manage and motivate internal teams on clinical trials.
  • Be able to mentor and coach others to improve conflict management skills; address conflicts, negotiate agreements, settle disputes equitably, and take responsibility for decisions.
  • Demonstrate team-building capabilities, including sharing success, fostering open dialogue, enabling colleagues to own their work, defining success collectively, and building team morale and belonging.
  • Take personal responsibility for results and push self and others to exceed goals and deliver results.
  • Demonstrate adaptability and poise amid uncertainty and organizational change.
  • Demonstrate diverse leadership capabilities, including influencing and collaborating with peers, developing and coaching others, overseeing and guiding colleagues' work to achieve outcomes, and creating business impact.
  • Must be authorized to work in the United States by any employer and maintain permanent work authorization in the United States.

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, Research & Development.
  • 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, as needed, partner with external companies.
  • Serve as an internal subject matter expert in the therapeutic area and clinical drug development.
  • Assume other clinical leadership responsibilities supporting 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 to 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 trade-offs and milestones and deliver the clinical program within agreed timelines and budget.
  • Develop comprehensive clinical development plans to secure global approval and reimbursement, including in China and Japan, and create pediatric investigation/study plans and protocol design documents in collaboration with trial clinicians to ensure feasibility and optimized operational execution.
  • Provide product- and program-specific input for target product profiles.
  • Develop clinical-development-enabling strategies, including digital innovation and patient engagement approaches.
  • Partner with trial clinicians on governance reviews, including science and operations reviews, and provide clinical development strategy input and insights for assigned studies.
  • Provide therapeutic-area and indication expertise in clinical data review, including case report form design, signal interpretation, and contextualization of adverse events.
  • Provide specialized medical monitoring support for 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; own 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 development.
  • 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.

Desired Qualifications

  • Experience designing and launching large teams.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

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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