Associate Medical Director, Clinical Research

Job Duties and Responsibilities

• Demonstrate ownership of the design and implementation of a clinical protocol that supports the product development plan, based on strong medical and scientific principles. An emphasis on hematological malignancies is preferred
• Provide clinical and medical input to protocols, regulatory documents, publications, and site/investigator interactions especially in complex patient cases
• Respond to site questions related to eligibility, concomitant medication assessments, dose modification guidance, and provide investigator medical support
• Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data
• Conduct study support, data review and query of sites, and provide scientific leadership with clinical research scientists
• Present at scientific, medical, and regulatory meetings globally
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups
• Contribute to company’s planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents
• Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
• Maintain ethical standards of the highest level
• As required by program needs, contribute to partnership with Discovery colleagues to the design and implementation of translational strategies
• Participate in meetings and committees of parent company or other affiliates. Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates. Work in close collaboration with the late-stage development group
• Perform other duties as requested

Key Core Competencies

• Ability to run a complex clinical research program with some direction
• An extensive knowledge of hematological malignancies is preferred
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
• Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive
• Able to lead through influence
• Excellent communication and presentation skills are essential

Education and Experience

• Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD
• Completion of a residency program strongly preferred
• Completion of a subspecialty fellowship is desirable
• Experience in blood cancers or solid tumors desirable
• 0 to 3 years of pharmaceutical drug development experience required

Travel Requirements

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.