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Vice President, Clinical Development
4 months ago
- Manage and provide medical oversight and monitoring of clinical programs
- Develop, review, and assess clinical trial protocols and clinical reports
- Provide medical input on safety and efficacy decisions, and ensure compliance with regulatory requirements
- Develop medical strategy for clinical development
- Serve as a key clinical representative for external-facing interactions for the program
- Establish and cultivate relationships with key opinion leaders, including leading advisory boards
- Review and assess data from clinical trials, including safety and efficacy, and provide medical input
- Collaborate with other line functions to assess data from clinical trials including biomarkers, pharmacokinetics, and pharmacodynamics
- Lead review and assessment of medical issues related to clinical trials
- Work with other medical directors, clinical scientists, and clinical operations personnel to ensure that study objectives are met according to program timelines
- Review and provide medical input on clinical trial reports
- Review and provide medical input for the development of clinical study materials
- Participate in the review of investigator and clinical site selection
- Work with clinical operations personnel to identify and address safety and efficacy issues
- Collaborate with external clinical experts and contract-research-organizations as needed
- Participate in strategic interactions with the research discovery group on internal pipeline molecules, initial clinical development and prioritization
- MD, PhD, or equivalent with a minimum of 5 years of experience in oncology clinical development
- Experience in conducting early phase oncology trials (Phase I/II)
- Experience in small molecule targeted therapeutics in oncology including breast cancer and lung cancer a plus
- Experience with medical monitoring
- Knowledge and experience in the principles of clinical trial design, clinical trial safety, pharmacokinetics, and pharmacodynamics
- Experience in the management of clinical trials and clinical data management
- Knowledge of clinical trial regulations and Good Clinical Practices (e.g., ICH GCP)
- Strong understanding of integrating pre-clinical and clinical data into decision-making
- Excellent written and verbal communication skills
- Strong problem-solving and analytical skills
- Ability to work efficiently in a multi-functional clinical program team
