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)