Director, Program Management

We were founded with the mission to develop novel, targeted therapeutics to improve the health and extend the lives of patients with cancer.

The primary role of the SVP, Clinical Development will be to provide medical leadership and direction for our pipeline of clinical development programs. The SVP Clinical Development will be responsible for developing and managing relationships with key opinion leaders in the medical community, keeping abreast of the competitive landscape, and advising on positioning of our products in the treatment landscape. The candidate should be board certified and have a strong drug development background in oncology and proven expertise with the design and execution of programs investigating therapeutic biologics. The candidate must have excellent organizational and interpersonal skills, as well as be able to work independently, with the ability to communicate effectively across internal teams and CROs. This position is responsible for ensuring the accuracy and completeness of all medical data in the trial databases. The SVP Clinical Development will serve as a key member of the executive team and will participate in strategic planning, internal and external partnering and financing discussions, and presentations to our Board of Directors. This is a highly critical and visible role, making significant contributions to the company beyond the scope of clinical and medical insights and guidance.

Key Essential Functions:

• Ownership of the clinical development and strategic direction of the oncology portfolio
• Understanding where the products in the portfolio could sit within the broader landscape
• Working with advisory boards to lead the clinical science side of the business
• Driving the clinical programs forward to registration
• Provide medical leadership and clinical strategy to the development team
• Represent medical in review/development of safety reports, safety events, and safety summaries, ensuring medical analysis and interpretation of data
• Lead interactions with key opinion leaders, investigators, and other clinical stakeholders and represent the company to external audiences
• Provide medical input and oversight on regulatory document preparation and interactions with Health Authorities
• Responsible for ensuring accuracy and completeness of all medical data in the trial databases
• Support and drive as needed the development of publications and posters
• Address inquiries from Investigators on eligibility and patient management
• Organize and deliver relevant training to Medical Affairs Operations / CRO staff
• Participate in the preparation and review of clinical study reports
• Represent the company in due diligence activities
• Manage regulatory, medical affairs and drug safety

Required Skills & Abilities:

• Strong knowledge of clinical trials and study designs.
• Medical practice experience in oncology
• Excellent oral and written communication skills, ability to work productively in a fast-paced and collaborative team environment
• Ability to work independently in virtual R&D organization with demonstrated ability to independently design and execute experimental plan
• Excellent organization skills with acute attention to detail
• Outstanding medical and scientific writing/editing skills with strong critical thinking and analytical skills

Required Qualifications:

• A Doctor of Medicine degree (MD)
• Minimum 10 years’ experience in clinical development or medical affairs
• Minimum 8 years’ experience in oncology
• Travel of up to 20% may be required