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Medical Director, Clinical Research & Development
The Clinical Research Physician, Hematology/Oncology, Immuno-Oncology will be instrumental in supporting the growth of the organization as it continues to build the value of its current products and develop new products. The incumbent will have hands-on responsibility designing and executing clinical trials focused on assigned therapeutic areas and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. This opportunity will involve multiple immuno-oncology products with an emphasis on T cell therapies. This is a hands on position and will require substantial travel to clinical sites throughout Europe during the initiation and conduct of the clinical trials.
Responsibilities will include, but are not limited to, the following:
• Drive clinical trial protocol development and execution through regulatory filings.
• Prepare, present and manage materials for external advisory boards to guide protocol and product development.
• Provide medical guidance to investigators on managing patients on clinical protocols.
• Interact seamlessly with biomarker translational scientists to inform and refine clinical product development and strategy
• Provide therapy area medical and scientific expertise to study teams and key stakeholders.
• Build and own investigator relationships across Europe for multiple indications and protocols.
• Provide clinical leadership to allow for initiation of trials in EU in collaboration with regulatory and clinical operations team members.
• Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
• Provide input into clinical sections of IND’s, Investigator Brochures, CTA’s , ISS’, ISE’s and clinical expert reports.
• Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area.
• Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
• Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL’s.
• Clinical expertise in the treatment and management of patients with hematologic malignancies and/or patients undergoing allogeneic stem cell transplant.
• Working knowledge of Good Clinical Practice and clinical research.
• Excellent written and spoken communication skills
• Keen ability to analyze clinical efficacy, safety, and biomarker data
• Interest/ability to evaluate early stage assets and participate in Business Development Due Diligence