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Clinical Lead, Internal Medicine Research Unit- Obesity
3 months ago
ROLE SUMMARY The Clinical Lead (CL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of metabolic 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 obesity and associated conditions (e.g., cardiovascular disease, renal impairment, 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 ensure excellence of project plans and team leadership to deliver successful POCs quickly, cheaply and competitively. Interfaces with other discipline leads to ensure operational excellence in the execution of the project's strategy. QUALIFICATIONS MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training. Approximately 8-10 years relevant experience Preference for established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Firm understanding of the drug development process with particular emphasis on early clinical development. Scientific excellence; possesses deep knowledge of integrated metabolism biology and metabolic diseases such as obesity, diabetes, 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, and integrating these plans into a cohesive overall clinical development strategy. Strong understanding of the complexities and current developments in the relevant disease/technical area, and skillfully applies this knowledge to drug development. Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. Experienced with ownership of budgets and sound financial risk management. Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results. Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback. Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography. PREFERRED QUALIFICATIONS Board eligibility/certification in Internal Medicine, with subspecialty training in obesity medicine and/or endocrinology (or analogous relevant subspecialty training) preferred. Active medical license preferred. #J-18808-Ljbffr
