Sr Director, Global Translational Sciences Lead, Molecular Imaging

Bayer Inc.•Whippany, NJ

56d•Hybrid

About The Position

The Senior Director, Global Translational Sciences Lead, Molecular Imaging is responsible for driving the development of translational and biomarker objectives for preclinical and early clinical strategies in support of Bayer Radiology Nuclear Medicine diagnostic radiotracer assets. In this role, you will focus on innovating and adding value to patients by differentiating radiopharmaceuticals for use as targeted diagnostics and/or therapeutics and driving translational understanding of clinical trial data.

Requirements

Minimum of a Master's Degree, MD, PharmD, or PhD in Molecular Imaging/Nuclear Medicine or a related field
At least 10 years of experience in the Pharma Industry, with 5 or more years in Translational Science/Medicine and/or Early Clinical Development (Phase 1-2a) of Radiopharmaceuticals, preferably in diagnostic radiotracers
A track record of clinical trial management/operations of Radiopharmaceuticals and broad knowledge of the drug development field, including experience leading CROs for translational studies and biomarkers for clinical trials
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
Proven understanding/expertise of radiopharmaceutical mechanisms of action, including chemistry, physio- and pathophysiological mechanisms, clinical biomarker development, and pathways of disease and treatment of TRTs and PET/SPECT tracers
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

Experience with other international health authorities and their regulatory requirements
Knowledge of TRTs and PET/SPECT tracers in the context of disease pathways and treatment

Responsibilities

Ensure effective collaborations between preclinical research and clinical development, establishing strong target-to-disease connections for radiotracers as standalone diagnostics or in co-development with targeted radiotherapies (TRTs) or other therapeutics
Integrate and validate technical knowledge of radiopharmaceuticals' mechanisms of action and identification of imaging biomarkers in preclinical development into strategies for the clinical development of diagnostic assets
Develop the overall early clinical development strategy of radiotracer assets in co-creation with relevant thought-leader communities, vendors, and partners with a central customer/patient value approach
Develop and oversee clinical trial designs (First in Human to Phase 2a) for radiotracer assets, in collaboration with vendors and partners
Lead the matrix-management of clinical trial teams, collaborating across the organization and externally with service providers/investigator sites
Lead all aspects of translational studies and deliverables with CROs and collaborators to support new and ongoing clinical studies
Provide technical expertise as required for the development, troubleshooting, and tech transfer of manufacturing methods to external vendors/partners
Support the development of cGLP and cGMP radiopharmaceutical manufacturing processes to enable clinical development activities
Review experimental data both internally and from external vendors/partners, analyze, summarize, and interpret results, and relay findings to stakeholders, internal and external (including representing Bayer at regulatory meetings) through summary reports, technical documents, or presentations
Author/co-author pre-clinical and clinical documents as applicable, such as IBs, protocols, study reports, statistical analysis plans, publications, and regulatory submissions
Support optimization of standard methodologies in clinical trial operations and adopt an open learning and sharing environment, optimizing methodologies and utilizing digital tools in clinical trials
May support and contribute to Business Development & Licensing (BD&L) activities
Mentor colleagues and promote knowledge-sharing