Clinical Lead (Senior Director), Internal Medicine Research Unit

ROLE SUMMARY

The Clinical Lead (CL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of cardiometabolic diseases at Pfizer. S/he will be responsible for creating the overarching strategy for early clinical development programs with a focus on innovative design, medical and scientific excellence, and the highest ethical standards. He or she will lead clinical development strategy and program execution of research projects with a particular focus on cardiometabolic diseases and associated conditions (e.g., cardiovascular disease, heart failure, renal impairment, obesity, diabetes, etc.), and lead translation of pre-clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof of mechanism and proof of concept for new candidate medicines. The CL will apply deep medical and clinical knowledge to translate clinical research ideas into high-quality decision-making data, working closely with subject matter experts from statistics, clinical pharmacology, and other team members. The CL serves as a single clinical development point of contact to the Research Project Leader for each assigned project. The CL will integrate scientific knowledge and operational expertise to ensure creativity, excellence, and integrity in clinical development. The CL also serves as principal contact on medical and safety issues for all study execution lines, study managers, external collaborators, and study sites during conduct of clinical trials. The CL establishes and cultivates collegial relationships with key clinical experts, academic entities, and clinical trial sites, and uses these relationships to help establish collaborations and enhance Pfizer's medical/scientific reputation. The CL will partner collaboratively across the enterprise, coordinating and integrating contributions from Discovery & Early Development lines and broader Pfizer Research & Development colleagues for the internal medicine therapeutic area to progress drug development programs.  S/he will ensure alignment and support from leadership stakeholders to streamline end-to-end clinical development plans. Overall, the Clinical Lead is positioned uniquely at Pfizer at the interface between bench and bedside, and plays a pivotal role in the ideation and maturation of leading edge clinical science applied to drug development.

ROLE RESPONSIBILITIES

• Uses deep medical and scientific knowledge and expertise to contribute to selection of targets for progression from chemical/biologic synthesis to testing in human.
• Leads the creation of the clinical development plan from pre-clinical stages through to proof of concept.
• Guides clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies. Creative in the conception of novel study designs and collaborates with the Clinician and Operations Manager to ensure these novel designs are optimized for operational effectiveness to ensure timely and cost effective delivery.
• Oversees the design and execution of clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies, etc.) including development of outline/core elements prepared by Clinicians or other clinical team members.
• Accountable for development of clinical documents (e.g., protocol, clinical report, clinical components of regulatory submissions). Clinical Lead provides final sign off for documents generated by Clinicians across the projects they are responsible for.
• Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking.
• Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with the Development Director, Operations Manager, and Clinician; accountable for final decision.
• Establishes relationships with key clinical experts/sites and uses this information to advise the clinical team on site selection
• Flexible in supporting a dynamic research portfolio; may need to manage multiple programs in parallel, depending on the development stage of the programs
• Contributes to technical and protocol review committees across the portfolio.
• May also hold concomitant functional roles, for example:
  • Translational Medicine Lead (TML) - Identifies / validates new / existing surrogate disease markers and novel pharmacodynamic measurements and helps translate preclinical knowledge to human decision criteria for clinical plans.
• • Research Project Leader (RPL) - Accountable for establishing and executing the strategy for a research project from target or compound selection to POC. Provides operational expertise to ens