Pfizer - Collegeville, PA

posted 3 months ago

Full-time - Senior
Collegeville, PA
Chemical Manufacturing

About the position

The Clinical Lead (CL) for Internal Medicine RU (IMRU) at Pfizer will serve as a pivotal thought leader in the clinical research domain, particularly focusing on the burgeoning field of cardiometabolic diseases. This role encompasses the responsibility of formulating a comprehensive strategy for early clinical development programs, emphasizing innovative design, medical and scientific excellence, and adherence to the highest ethical standards. The CL will spearhead the clinical development strategy and oversee the execution of research projects that target cardiometabolic diseases and related conditions, including cardiovascular disease, heart failure, renal impairment, obesity, and diabetes. This position requires the translation of pre-clinical observations into clinical experiments and studies aimed at establishing proof of pharmacology, proof of mechanism, and proof of concept for new candidate medicines. In this role, the CL will leverage extensive medical and clinical knowledge to convert clinical research ideas into high-quality decision-making data. Collaboration with subject matter experts from statistics, clinical pharmacology, and other team members will be essential. The CL will act as the primary clinical development contact for the Research Project Leader for each assigned project, integrating scientific knowledge with operational expertise to ensure creativity, excellence, and integrity in clinical development. Additionally, the CL will be the principal contact for medical and safety issues throughout the study execution process, working closely with study managers, external collaborators, and clinical trial sites. The CL will also be responsible for establishing and nurturing relationships with key clinical experts, academic institutions, and clinical trial sites, utilizing these connections to foster collaborations and enhance Pfizer's medical and scientific reputation. This role requires a collaborative approach across the enterprise, coordinating contributions from Discovery & Early Development lines and broader Pfizer Research & Development colleagues to advance drug development programs. The CL will ensure alignment and support from leadership stakeholders to streamline end-to-end clinical development plans, positioning them uniquely at the intersection of bench and bedside, and playing a crucial role in the ideation and maturation of cutting-edge clinical science applied to drug development.

Responsibilities

  • Lead the creation of the clinical development plan from pre-clinical stages through to proof of concept.
  • Guide clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
  • Oversee the design and execution of clinical research studies, including methodology studies, biomarker studies, proof of mechanism studies, and proof of concept studies.
  • Accountable for the development of clinical documents such as protocols and clinical reports, providing final sign off for documents generated by clinicians.
  • Serve as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking.
  • Provide input to the operational strategy and feasibility of clinical research studies, accountable for final decisions.
  • Establish relationships with key clinical experts/sites and advise the clinical team on site selection.
  • Manage multiple programs in parallel, depending on the development stage of the programs.
  • Contribute to technical and protocol review committees across the portfolio.

Requirements

  • MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training.
  • Approximately 8 years of relevant experience in clinical trials execution in the pharmaceutical industry.
  • Established record in managing complex projects and a firm understanding of the drug development process, particularly early clinical development.
  • Deep knowledge of integrated metabolism biology and metabolic diseases such as obesity, diabetes, cachexia, and cardiovascular/cardiometabolic disorders.
  • Superior clinical ability with relevant disease area knowledge and experience.
  • Ability to design, initiate, and conduct effective clinical studies applying novel principles as appropriate.
  • Strong understanding of clinical regulatory requirements, GCP, and ICH guidelines.
  • Experience with ownership of budgets and sound financial risk management.
  • Skilled communicator and team leader, able to articulate ideas and integrate feedback.

Nice-to-haves

  • Board eligibility/certification in Internal Medicine, with relevant subspecialty training (endocrinology, cardiology, nephrology or analogous subspecialty training) preferred.
  • Active medical license preferred.

Benefits

  • 401(k) plan with Pfizer Matching Contributions
  • Paid vacation, holiday, and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Participation in Pfizer's Global Performance Plan with a bonus target of 25% of the base salary
  • Eligibility to participate in share-based long-term incentive program
  • Relocation assistance may be available based on business needs and/or eligibility.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service