FierceBiotech and FiercePharma Jobs
Senior Medical Director - Endocrinology - Discovery Solutions
Nov 13
Location: Bedminster, NJCategories: Biotherapeutic
Website: http://discoverysolutions.net
Position Description
Senior Medical Director-Endocrinology
Job Description:
The Senior Medical Director will be responsible for providing leadership and ongoing clinical perspective to the research and development strategy of selected compounds mainly in the endocrinology area from preclinical through clinical development, regulatory approval and post-marketing activities.
Primary responsibilities:
Collaborate closely with the chief medical officer and head of clinical research, as well as with external partners on the development of selected compounds in the COMPANY portfolio and on the implementation of strategies to achieve key objectives and milestones.
Lead clinical development planning and oversee trial design and protocol development to achieve optimal speed, quality and economy for the lead programs spanning preclinical through Phase IV include managing activities of clinical research organizations or CROs.
In cooperation with regulatory co-workers represent and manage the company’s clinical programs to regulatory authorities and corporate partners.
Apply a blend of strategic skills combined with a practical, hands-on approach to ensure the timely execution of COMPANY’S product or indication development plans including oversight of CROs.
Build partnerships and relationships with the scientific and medical community including international scientific and professional organizations in the field of endocrinology.
Working with the senior management team, play a key role in establishing, maintaining and managing collaborations with strategic partners.
Work closely with business development, legal and other members of the senior management team to optimize the Company’s intellectual property portfolio, and provide support on technical due diligence and development associated with licensing, acquisitions and collaborations.
Represent the drug development group externally in scientific presentations, conferences and industry groups. Serve as spokesperson with KOLs.
Contribute to the positive, success-oriented, high performance culture that reflects the COMPANY values and attracts/retains talent.
Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
Requirements:
The successful candidate will have an MD or MD/PhD board certified in Endocrinology, Gastrointology, or related field.
A minimum of 7 years biotechnology/pharmaceutical experience ideally in the area of endocrinology, thyroid studies and parathyroid hormone.
Extensive understanding of the drug development process and regulatory guidelines including awareness of the interface between clinical research and preclinical development and a successful track record of taking products through the FDA to approval.
Experience with the execution of multiple clinical trials including early phase studies, regulatory agency interactions and responses.
A strong network and credibility with opinion leaders in the medical community.
