Clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer in various indications. Company highly touted in the industry with an extensive drug discovery and clinical development experience. Company is building a portfolio of therapies addressing a wide range of therapies for a multiple combination of regimens.
- Providing scientific and medical expertise to the design and implementation of phase I-III clinical studies to drive successful global filings.
- Providing strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment.
- Oversite of CRO medical monitors with primary sponsor responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
- Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration
- Responsible for clinical development plans and overall strategy for assigned compounds while taking into consideration ongoing developments in the area of clinical oncology and oncology drug development.
- Collaborate with pre-clinical, translational sciences, regulatory, and senior management in development of study protocols, clinical development strategy, and implementation of clinical strategy.
- Provide leadership on cross-functional product development team(s) as experience allows.
- Build and maintain solid working relationships with key opinion leaders, and lead clinical investigators.
- Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
- Partner with development team leads to formulate strategy and coordinate cross-functional planning and execution across multiple indications.
- Participates with clinical development in all aspects of NDA and sNDA applications.
- Engage with stakeholders at all levels of the organization to solicit input and feedback. Incorporate learnings into team direction setting, problem resolution and lessons learned activities.
- Motivate and facilitate informed, timely, and impactful decision making across the organization.
- Develop and maintain a high performing operational approach including effective team building and conflict management. Identify situations requiring escalation.
- MD degree required
- 5+ years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical, or CRO environment if oncology board certified/eligible OR 8+ years of experience in the pharmaceutical industry in a clinical development role if physician has oncology experience but is not oncology board certified/eligible.
- Oncology experience required.
- Experience with the clinical drug development process.
- Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents.
- Ability to handle complexity, prioritize and multi-task current project demands. Must be able to prioritize and deliver effectively with minimal supervision.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
- Ability to make sound and timely decisions; agile in learning and action oriented.
- High level of emotional intelligence; able to deal with ambiguity.
- Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams.
- Excellent written and verbal communication skills required.
- 15-20% travel
Salary up to $250K+ Annual Bonus + Incentives (Options, etc)
Mid-Atlantic states (Remote location acceptable)
No, not at this time.
PE - 1617