Medical Director, Oncology

Responsibilities:

• Act as clinical expert for both internal Company team members and for external contacts related to the assigned therapeutic programs
• Provide clinical and scientific leadership including training and ongoing input, to members of the Development and product Core Teams on issues related to the therapeutic field
• Provide medical oversight for Company operational staff, CROs and clinical trial sites in areas related to the oncology programs
• Design the clinical development plan for indications relevant to assigned molecules programs and support the assessment of the development plans through the cross-functional product core team
• Design, develop and implement clinical studies for the applicable drug candidate, from Phase I through Phase III
• Establish relationships with external experts in the scientific oncology areas, including principal investigators and opinion leaders, to facilitate scientific excellence in clinical trials research
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Participate in the writing and review of clinical protocols, investigator brochures, clinical study reports, publications and other documents
• Deliver timely and high quality clinical data
• Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Other duties as assigned

Preferred Skills, Qualifications and Technical Proficiencies:

• Candidates must be excellent communicators with proven leadership skills and the ability to successfully interact in a busy cross functional environment
• Ability to establish and maintain a team "sense of urgency" around timelines

Preferred Education and Experience:

• MD required
• Board eligible or certified in an internal medicine subspecialty required; oncology/hematology board certification/eligibility preferred
• 2+ years’ clinical development experience in the biotechnology/pharmaceutical industry or an academic clinical trial unit
• A proven track record of scholarly clinical research demonstrated by publications in top tier journals