Vice President, Clinical Research
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POST DATE 9/14/2016
END DATE 10/15/2016
JOB DESCRIPTIONSummary of Position:
The Vice President, Clinical Research will provide medical input to all aspects of product development from preclinical research, through Phase I/II/III Clinical Trials. Will have full responsibility for the leadership, planning, implementation and daily operation of drug development projects and providing medical expertise and leadership necessary to complete clinical study programs leading to the filing of Biologics Licensing Applications (BLA) to the FDA. He/she will develop a clinical development strategy, advise management, and participate in interactions with Regulatory agencies on behalf of the company. Will serve as the scientific and medical leader for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs and external principal investigators. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists. This position involves both high level strategic planning as well as hands-on responsibilities.
Responsibilities and Job Duties:
* In collaboration with colleagues in Clinical Development, Research, Product Development and Regulatory Affairs, external experts, and business partners in designing, implementing, conducting, and reporting of clinical trials conducted with the Company s products (protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting) that will maximize the potential for regulatory approval and commercial success.
* Direct and oversee the design and implementation of early stage clinical projects as a member of our Product Development Team (PDT) and leader of the Product Steering Team or Committee (PST). Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices.
* Present and defend protocols and clinical. development plans at internal governance forums.
* Responsible for the safety monitoring of clinical trials as the medical monitor, and as medical expert for Phase I/II and III studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
* Interact closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration.
* Ensures that study design is scientifically robust.
* Direct protocol implementation, including site identification and communication, attend investigators meetings, correspond with sites including IRBs, and interact with operations teams.
* Present study updates, interim results, and final headline data to senior management as required.
* Supports data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
* Serves as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), steering committees and data safety monitoring boards as required. and identifies and liaises with KOL regarding program strategy and scientific advice.
* Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
* Serves as an information resource to the Company with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
* Directly develops or guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high quality documents.
* Review potential in-licensing candidates and present recommendations to Senior Management groups. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
* Contribute and support department and clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
* Oversees, mentors and provides leadership to subordinates and colleagues involved in clinical trial execution.