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Medical Director

HK Recruiting

Medical Director

National
Full Time
Paid
  • Responsibilities

    Our client is a global, clinical stage biopharmaceutical company focused on the development of an innovative pipeline of new chemical entities with known mechanisms of action targeting underserved patient populations in organ protection and infectious diseases.

    Our client  utilizes an integrated discovery and development platform that enables the company to efficiently bring new therapies from bench to patients around the world.

    The Medical Director will support clinical development in infectious and/or pulmonary disease. The Medical Director works with cross-functional clinical study teams and provide clinical science support for assigned programs. The initial focus will be in leading designing clinical development protocol and clinical trial in late development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design, protocol development and study conduct.

    PRIMARY DUTIES:

    • Will have direct responsibility for the overall research strategy and clinical and scientific development activities for one or more compounds;

    • Drive development of clinical development plans and protocols for clinical studies;

    • May serve on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, monitoring and reviewing incoming safety &efficacy data, engaging with study physicians, reviewing final data outputs and other activities as needed.

    • Provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and toxicity management, in conjunction with external and internal partners.

    • Provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);

    • Provide clinical scientific input to business development (e.g. due diligence);

    • Develop and deliver presentations to internal and external stakeholders.

    • Elaborate and integrate the scientific and clinical rationales, regulatory requirements to support buidling a solid Clinical Development Plan (CDP), including appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.

    • Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice.

     

    EDUCATION AND EXPERIENCE:

    • MD/MD-PhD with infectious disease or pulmonology training;

    • At least five (5) years of experience with progressive responsibilities in drug development in industry (clinical trial experience mandatory).

    • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.

    • Ability to compile and present development plans, study designs, analyses of data in

      forums consisting of individuals representing a variety of functions (eg, both with and without scientific backgrounds).

    • Excellent communication skills (oral and written) and excellent organizational skills.

    • The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. Must be able to work with minimal supervision.

    • Ability to represent the department on project teams, committees and at external meetings.

    • Able to work collaboratively in a multi-disciplinary team setting and employ a team approach to decision-making.

    • Ability to balance multiple competing demands and meet aggressive timelines.

    • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20%-30% potential travel, adjusted as necessary for COVID-19).