Pfizer Senior Director, Clinical Lead, Neurodegenerative Diseases Internal Medicine (MD REQUIRED) in Cambridge, Massachusetts
The Senior Director, Clinical Lead (CL), Neurodegenerative Diseases, Internal Medicine Research Unit (IMRU) plays a key role in advancing Pfizer's clinical and translational research efforts in neurodegenerative diseases (e.g. Alzheimer's Disease and Parkinson's Disease). Key responsibilities include creating the overarching clinical strategy for early development programs with a focus on innovative design, medical execution and interpretation.
Key responsibilities include creating the overarching clinical strategy for early development programs with a focus on innovative design, medical execution and interpretation. He/she serves as CL for these programs and may engage at stages from lead development through proof of concept (POC), guiding translation of preclinical observations into clinical experiments and results. The CL is responsible for development of methodologies to support proof of pharmacology, proof of mechanism (POM) and POC studies. He/she applies medical, scientific, and clinical development knowledge to translate research ideas into high quality clinical study protocols that provide clear decision-making data. The CL serves as a single clinical development point of contact to the Research Project Leader for each assigned project. The CL works closely with statistics, clinical pharmacology and other disciplines in the planning and conduct of studies, and in the review, analysis, and reporting of the resulting data. The CL also serves as principal contact on scientific and medical issues for project managers, study managers, external collaborators, and study sites during the conduct of clinical trials. He/she must establish collegial and productive working relationships with key clinical experts/sites and use these relationships to help establish collaborations and enhance Pfizer's medical/scientific reputation.
The CL promotes scientific and technical excellence in the preclinical domain by providing clinical knowledge and expertise for the advancement of compounds from Lead Development to First in Human (FIH) studies. To promote success in late development efforts, the CL works with Global Product Development (GPD) Colleagues to develop success criteria for POC studies for each drug candidate and to ensure alignment from both IMRU and GPD leadership in order to streamline end-to-end clinical development plans.
The CL may also participate actively in relevant above-asset and/or external collaborative activities, eg, the development of novel/emerging disease or indication-specific biomarkers and endpoints that will aid clinical development for neurodegenerative disorders. He/she may also provide scientific knowledge and clinical expertise to Colleagues in Business Development in support of licensing and partnering activities.
Leads the creation and updating of the clinical development plan for assigned projects from Discovery through outcome of POC.
Oversees the design and execution of clinical research studies of various types necessary to advance projects through early development (eg, methodology, biomarker, clinical pharmacology, POM and POC studies) through application of cutting-edge medical and clinical development knowledge.
Guides Study Teams to assure excellence in development and translation of clinical trial designs into efficiently delivered studies, including development of study outlines/core elements prepared by Clinicians or other clinical team members. Provides input to the operational strategy and feasibility of clinical research studies, in the context of matrixed teams, including the Clinical Project Manager, Operations Manager, and Clinician; accountable for final decisions. Establishes relationships with key clinical experts/sites and uses this information to advise the clinical team on site selection.
In collaboration with Clinicians, tracks emerging study data to ensure appropriateness of the chosen subject population, assess the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality, and evaluate and respond to any emerging safety findings. During the conduct of individual studies and across studies keeps the Clinical Research Head informed of relevant changes in the safety profile and recommends appropriate courses of action (e.g., additional monitoring, intermediate doses, discontinuation, etc.).
Is accountable for development of clinical documents (e.g., protocols, clinical study reports and clinical components of regulatory submissions), providing signoff for documents generated by Clinicians.
Demonstrates inquisitiveness and creativity in the conception of novel study designs, collaborating with Clinicians and Operations Managers to ensure that novel designs are optimized for operational effectiveness, thereby achieving timely and cost effective delivery. Applies learnings/ best practices from the external environment to improve Pfizer's early development strategies and processes.
Builds relationships with external investigators to promote scientific discussions, smooth operational delivery and avid interest in Pfizer's success.
Maintains a high degree of awareness of the external environment and helps appropriate external clinical development innovations to be used in research programs. In particular, maintains medical and scientific expertise in novel techniques and educates others in their application. Understands and applies such techniques in clinical studies and works with the relevant platform and partner lines to overcome challenges so that resulting study data are captured and analyzed in a timely and effective manner.
Supports Discovery efforts by using personal medical and scientific knowledge and expertise to provide input to advancement of therapeutic agents from LD to FIH. Contributes expertise to building appropriate translational pharmacology models from LD through POC. Collaborates with the RPL and the Project Team to assure that the translational research plan supports the clinical development strategy; responsible for the creation of project biomarker strategy and plan to achieve POM.
Motivates and engages Colleagues in an understanding of neurodegenerative diseases and excitement about indications and their underlying pathophysiologic mechanisms.
Maintains a flexible stance toward the support needs of a dynamic research portfolio; may need to manage up to 4 projects in parallel, depending on their development stage.
May also hold concomitant functional roles, eg:
Translational Medicine Leader: identifies/validates new/existing biomarkers and novel pharmacodynamic measures that may reduce the cost of drug R&D. Helps translate preclinical knowledge to human decision criteria for clinical plans.
RPL: Accountable for overall strategic and operational advancement of a research project from FIH to POC. Provides expertise to assure excellence of clinical development plans and team leadership to deliver successful POCs quickly, cheaply and competitively. Interfaces with leaders of disciplines involved in projects to assure operational excellence in the execution of project strategy.
Contributes to technical review committees across the portfolio.
EEO & Employment Eligibility
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Additional Offer Details:
Eligible for Relocation Package: yesEligible for Employee Referral Bonus: yes
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