Senior / Executive Medical Director (Florham Park)

The (Senior / Executive) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive along with strong hands-on experience to help the organization succeed.

MAJOR RESPONSIBILITIES AND DUTIES

• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Design Comprehensive Development Plans (CDPs), clinical trials and protocols and execute in accordance with applicable Good Clinical Practice (GCP) regulations.
• Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)
• Define project timelines & deliverable, working closely with cross functional team and assure that deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards.
• Identify project risks with input from the cross functional teams, and support resolving issues.
• Provide therapeutic area medical and scientific expertise to study teams and key stakeholders.
• Anticipate trends in medicine and industry that may / will have an impact on the clinical / commercial viability of products and factors into planning.
• Engage and inspire the project / clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
• Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality.
• Interact with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA / MAA meetings, Advisory Committee meetings, or other scientific advice forums.
• Performs all duties in keeping with the companys core values, policies and all applicable regulations.
• Ensure data review quality (e.g. patient eligibility, Protocol Deviation review, efficacy and safety review) and data accuracy.
• Conduct safety review and safety follow up.
• Interpret data and ensure CSR quality / Briefing book quality.
• Interact with the HA and IRB / EC and Answers to medical questions raised by EC / IRBs and sites; identify the need of protocol amendment and maintain appropriate compliance with protocols.
• Interact with the participant Principle Investigators on protocols.
• Conduct literature research and competitive intelligence tracking for assigned projects.

QUALIFICATIONS