Sr Director, Global Clinical Lead, Diagnostic Molecular Imaging

Bayer CropScience Ltd•Whippany, NJ

58d•Hybrid

About The Position

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.

Requirements

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 disease and treatment of TRTs and PET/SPECT tracers, preferably in Oncology. Cardiovascular and/or Neurology experience will also be considered
Demonstrated capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss, and present clinical trial or section program-level data
Proven experience with FDA regulatory requirements and ICH GCP guidelines for the development of radiopharmaceuticals, preferably diagnostic radiotracers (IND submission, FDA formal meetings, etc.). Experience with other international health authorities will be valued
Demonstrated ability to establish strong scientific partnerships with key stakeholders
Strong VACC (visionary, architect, catalyst, coach) leadership behaviors
Excellent communication and presentation skills (fluent in business English), with clear written and verbal expression of ideas and an active communicator

Nice To Haves

Additional qualifications in MI/Nuclear Medicine (e.g., board certification, PhD, or other relevant education in the field)

Responsibilities

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