Teva Head Precision Experimental Medicine 

United States, New Jersey 

677505437

Travel Requirements: Approximately 10-20% - presentations and/or attendance at 2 or more domestic and/or 1 or more domestic + 1 international scientific association meeting per year, plus key opinion leaders, scientific advisory boards regulatory meetings, academic collaborations, consortia, and other strategic meetings as required.

The candidate hired for this position will be required to work onsite as needed out of the Parsippany, New Jersey office

• The Senior Precision Medicine Lead (PML) supports asset programs by enhancing the probability of success and de-risking the development of Teva’s early drug candidates.
• The SPML is accountable for the planning and execution of the Experimental Clinical Development Plan and for providing clinical and scientific input into the overarching Translational and Precision Medicine Strategy in accordance with Teva priorities.
• Collaborates with TPM TA Heads, the TA and clinical development leadership to enhance candidate selection and develops comprehensive clinical and scientific de-risking plans for the assigned drug candidate(s) to move into the late stage of clinical development.
• Leads a cross-functional Early Clinical Development Team(s) and is responsible for the design, planning, executional oversight, medical monitoring, and interpretation of Experimental Clinical Studies (including Phase 0, Phase 1b, proof of activity and concept, adaptive, master protocol, window of opportunity studies) and ensures that clinical studies operate with scientific rigor, comply with the highest ethical and safety standards and are compliant with clinical, ICH and GCP guidelines as well as Teva SOPs.
• Oversees and supervises clinical development leaders and physicians in conducting early clinical studies.
• Identifies and seeks to validate novel endpoints for early decision making and identifies patient or target population stratification strategies to support the rapid demonstration of safety and efficacy (surrogate biomarkers, intermediate clinical endpoints, digital COAs).
• Reviews preclinical data for clinical implications and integrates preclinical information to progress molecules from nomination to early clinical development stages.
• In collaboration with other functions, leads the development of the study concept and related documents and the delivery of the final protocol and its governance approval.
• Responsible for providing clinical input into the implementation of a clinical trial(s), their management, clinical data review, and interpretation of results.
• Serves as the main point of contact for clinical issues raised by collaborators, investigators, and consultants, provides ongoing medical input into study documentation, and participates in the pharmacovigilance reporting process.
• Conducts the analysis and interpretation of interim and final study data, writing of final study reports and summaries for regulatory submission.
• Leads the dissemination of study data and results internally and externally, including the development of publications, abstracts, and presentations.
• Participates in the planning, writing, and leading relevant modules of regulatory documents and applications, represents clinical strategy and study results and interpretation at regulatory interactions, as appropriate.
• Represents Teva at scientific meetings, advisory boards, KOL boards, and meetings with regulatory agencies, as needed.
• Forms and fosters partnerships with a wide spectrum of external experts and collaborators, agencies, academic and industry opinion leaders.
  

Required:

• M.D. or M.D./Ph.D. from an accredited medical school with training in Pharmacology, Molecular Biology, Biochemistry, Genetics or Related Disciplines
• Minimum of 10 years of early clinical research and drug development experience, experience in translational and precision medicine research and biomarker sciences.
• Minimum 3 years of managerial experience.

Preferred:

• Early clinical research (designing and managing clinical studies, ICH, GCP, GLP) and drug development experience.
• Experience with regulatory process, guidelines, and interactions.
• Project and people management, and leadership experience.

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