Executive Director, Asset Development

Role Overview

• Primary responsibility for strategy, oversight, and delivery of end-to-end activities involving new or marketed drug(s) for oncology indications.
• Lead the team responsible for cross-functional delivery of critical milestones in oncology asset’s lifecycle, spanning discovery through reimbursement.
• Creation, alignment, execution, and adaptation of the asset strategy cross-functionally
• Lead the asset development team to maximize the asset’s potential
• Identifying registrational opportunities for pre-clinical and early clinical candidates which have potential to become medicines
• Evaluating pre-clinical and translational work for the purpose of strategizing early clinical development plan and Investigational New Drug applications
• Working with relevant clinical teams to develop clinical development strategies for investigational or marketed assets
• Prioritizing clinical trials (design, operational plans, settings) based on these clinical development strategies
• Support asset specific biomarker strategy and diagnostic readiness
• Support asset specific safety management such as safety governance meetings, dose adjustments, supportive care optimization
• Leading development and communication of the messaging around the asset and the asset strategy
• Lead interactions with governance to secure alignment and support for asset development
• Participation in internal and joint internal/ external research project teams relevant to the development of new compounds.
• Mentoring and career development for direct reports (when applicable) will be a key function of the role.

Requirements

• M.D., or MD/PhD with experience in oncology
• Minimum of 5 years of industry experience in drug development in a relevant therapeutic area
• Minimum of 5 years of clinical experience
• Designed, executed, and reported out phase 3 or registrational studies
• Supported or led submission activities for labels, supported in post approval launch readiness such as publication planning, guideline submission, HTA negotiations.
• Experience navigating a matrixed structure including shepherding studies/concepts through internal governance boards
• Expertise as clinical lead for interactions with regulatory agencies.
• Understanding the impact of drug manufacturing parameters on drug development execution
• Strong interpersonal skills, as well as the ability to function in a team environment are essential
• High level of verbal and written communication, including presentation skills.
• Strong learning agility and growth mindset
• Experience with multiple modalities of therapies (biologics, small molecules, etc.)

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days