Pfizer Executive Director, Clinical Lead, Internal Med RU (MD REQUIRED) in Cambridge Kendall Sq. 610 Main, Massachusetts
The Clinical Lead (CL), Internal Medicine RU (IMRU) will be responsible for creating the overarching strategy for early clinical development programs with a focus on the highest ethical standards, innovative design, medical execution and interpretation. He or she will lead clinical development strategy and program execution of research projects with a particular focus in metabolic diseases (e.g., NASH, diabetes, and cardiometabolic illness), and lead translation of pre-clinical observations into clinical experiments and results. The CL is responsible for development of methodologies to support proof of pharmacology, proof of mechanism and proof of concept studies. They will apply medical and clinical development knowledge to translate clinical research ideas into high quality clinical candidate and target go/no-go decisions; working with statistics and other clinical staff (e.g., clinical pharmacology) in the review and interpretation of data, they will be accountable for overall quality and timeliness of analysis and reporting. 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 excellence in development and translation of clinical research plans into efficiently delivered studies. The CL also serves as principal contact on scientific and medical issues for all study execution lines, study managers, external collaborators, and study sites during conduct of clinical trials. The CL establishes collegial relationships with key clinical experts/sites, and use these relationships to help establish collaborations and enhance Pfizer's medical/scientific reputation. The CL drives scientific and technical excellence, partnering with Early Clinical Development colleagues in clinical sciences, clinical pharmacology, and statistics to ensure optimal study design and execution, and provides input to the selection of targets at Lead Development to be progressed to clinical testing. The CL will partner with Global Product Development leads for the IM therapeutic area to develop success criteria for proof of concept studies for each drug candidate and will ensure buy-in and alignment from their respective leadership to streamline end-to-end clinical development plans.
Motivates and engages colleagues in an understanding of disease and excitement in an indication and mechanism.
In collaboration with the RPL and the Research Project Team, ensures that the translational research plan supports the strategy for clinical development; responsible for the creation of each program's biomarker strategy and plan to POM.
Leads the creation of the clinical development plan from PRISM through to outcome of POC.
Guides clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
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 resource to the Clinician in the development of outline/core elements and for clinical review and safety oversight.
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 advice the clinical team on site selection
Builds relationships with external investigators to promote scientific discussions, smooth operational delivery and avid interest in Pfizer's success.
Be outward facing including learning/applying best practice from the external environment and being the key point of contact for clinical research.
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.
Maintains a high degree of awareness of the external environment and ensures appropriate external innovations in scientific and medical aspects are applied to the research portfolio.
Understands and applies novel techniques and works with the platform lines to overcome potential barriers to ensure novel study data is captured and analyzed in a timely and effective manner.
Maintains medical and scientific expertise in novel techniques and educates others in their application.
In collaboration with the Clinician, tracks emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality.
In collaboration with the Clinician, tracks the emerging safety profile of the drug, keeping the Clinical Research Head informed of relevant changes in the safety profile and recommending appropriate courses of action (e.g., additional monitoring, intermediate doses, discontinuation, etc.) as needed during the conduct of the assigned studies.
Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking.
Flexible in supporting a dynamic research portfolio; may need to manage two to four programs in parallel, depending on the development stage of the programs
Contributes to technical and protocol review committees across the portfolio.
Contributes expertise to building appropriate translational pharmacology models spanning from idea through to POC
Uses personal medical and scientific knowledge and expertise to input to selection of targets for progression from LD to testing in human.
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.
MD or MD/PhD with relevant postgraduate clinical training.
Approximately 15 years related experience, including 7-10 yrs of industry experience.
Established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Comprehensive understanding of the drug development process with particular emphasis on phase Ia/Ib and IIa/IIb clinical trials.
Scientific excellence; possesses deep knowledge of integrated metabolism biology and clinical metabolic diseases such as NASH or diabetes.
Superior clinical ability with relevant disease area knowledge and experience.
Demonstrated 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.
Demonstrated understanding of the complexities and recent developments in the relevant disease/technical area, and ability to apply such knowledge to drug development.
Comprehensive understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
Understands the value of project management and is able to leverage these tools for project delivery.
Experienced with ownership of budgets.
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.
Board eligibility/certification in Hepatology, Endocrinology, Cardiology and/or Heart Failure/Cardiomyopathy preferred.
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
The CL will be a matrix manager of project teams, specifically heading the clinical subteam of the global medicines team for each asset assigned.
The CL may be asked to lead above asset working teams or subteams thereof, matrix managing small or large teams comprised of colleagues from across business lines (e.g. WRD, GPD, PIH).
The CL may also serve as an RPL or TML, which are roles that require matrix management of teams varying in size from 3-20 based on stage of development and project complexity.
May also directly manage from 1-10 colleagues of varying experience and seniority, including other clinical leads and clinicians, depending on business needs and personnel staffing.
EEO & Employment Eligibility
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Other Job Details:
- Eligible for Relocation Package - Yes
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