Sr Director, Global Clinical Lead, Diagnostic Molecular Imaging

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Sr Director, Global Clinical Lead, Diagnostic Molecular Imaging 

The Senior Director, Global Clinical Lead Diagnostic Molecular Imaging is responsible for leading the strategic conceptualization, design, execution, and oversight of the clinical development programs of diagnostic drug Molecular Imaging (MI) assets in Radiology. This role encompasses clinical development phases from Phase 1 to Phase 3, with an emphasis on late-phase development. You will focus on the purposeful generation of clinical evidence supporting the added clinical value of diagnostic radiopharmaceuticals as stand-alone and/or theragnostic pairs. This includes working within a constellation of diagnostic medical device and software assets in the Radiology MI space and therapeutics in the pharmaceutical space, while supporting regulatory and market access requirements in relevant markets.

YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Director, Global Clinical Lead Diagnostic Molecular Imaging, are to:

• Represent Clinical Development Radiology for Molecular Imaging diagnostic drug assets globally;
• Ensure effective collaborations between capabilities overseeing early development stage assets (e.g., Translational Sciences) and relevant late-stage capabilities, establishing value for radiotracers as standalone diagnostics or in co-development with targeted radiotherapies (TRTs) or other therapeutics;
• Support and contribute to Business Development & Licensing (BD&L) activities;
• Lead the development and execution of the clinical strategy for diagnostic radiopharmaceuticals, including the development of an endorsed Clinical Development Plan in line with the Target Product Profile, designed for successful regulatory approval and market access for one or multiple treatment indications and/or multiple programs;
• Develop the overall early clinical development strategy of radiotracer assets with a central customer/patient value approach in collaboration with internal Radiology capabilities, partners, thought-leader communities, vendors, regulatory authorities, and other external partners;
• Lead or author the creation of clinical documents or components of key documents (e.g., Clinical Study Protocol, Investigator Brochure, Clinical Study Report, regulatory documents, etc.);
• Develop and oversee clinical trial designs (with a focus on late-stage Phase 2b to Phase 3) for radiotracer assets, in collaboration with vendors (such as operational CROs, imaging CROs, CDMOs, etc.) and partners;
• Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s);
• Lead the matrix-management of clinical trial teams, collaborating across the organization and externally with service providers and investigator sites;
• Review clinical trial data both internally and from external vendors/partners, analyze, summarize, and interpret results, and relay findings to stakeholders (internal and external, including representing at regulatory meetings) through summary reports, technical documents, or presentations;
• Support optimization of standard methodologies in clinical trial design and operations, adopting an open learning and sharing environment, and utilizing digital tools in clinical trials;
• Mentor colleagues and promote knowledge-sharing.
• The primary location for this role is Whippany, NJ, however, residence based candidates in the US will also be considered provided they are willing to travel.

WHO YOU ARE
Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Medical Degree (MD) or equivalent;
• At least 10 years of experience in a Pharma Industry environment, with 5 or more years in clinical drug development, spanning clinical activities in Phases 1 through 3 and experience with leading submission dossiers;
• Relevant experience (>5 years) in clinical development of Radiopharmaceuticals (diagnostic radiotracers and/or Theragnostics) and pathways of di