Job Description

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 company’s 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

• MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area;
• 5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Director.
• Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
• Knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
• Experience in biotech is preferred.
• Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment.
• Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams.
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

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