Vice President, Early Oncology Clinical Development

Role Summary

Vice President of Early Oncology Clinical Development. Lead medical direction, management, and review of early oncology clinical trials and product development; oversee strategy and design of development programs, protocol development, medical monitoring, data analysis, and regulatory documentation. Will interact with multiple functions to ensure progress of projects and trials; requires strong leadership and cross-functional influence in a fast-paced environment.

Responsibilities

• Oversees all early oncology development program activities and is responsible for execution of programs and timelines
• Applies disease knowledge to clinical research trial development
• Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions
• Drives preparation of clinical development plans in partnership with cross-functional teams
• Works collaboratively with associated clinical functions to oversee and participate in drafting clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
• Contributes to CSR preparation and finalization
• In association with clinical operations colleagues and clinical scientists, contributes to the development of CRFs and data review plans when needed
• Oversees the Monitoring and review of safety and efficacy data in ongoing studies
• Serves as the key decision maker for clinical questions associated with eligibility, AE management, etc. for clinical studies
• Participates in developing clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training where needed
• Develop and participate in advisory boards
• Keeps abreast of hematology/oncology treatments, drug mechanism of action, approaches to drug development and regulatory requirements
• Acts as a clinical representative in variety of cross-functional and executive teams
• Partners with Research, Translational/Biomarker and other Preclinical teams to help guide advancement of drug candidates with meaningful safety: efficacy profiles
• Serves as clinical partner for Business Development

Qualifications

• Medical degree and medical oncology training required
• Minimum of ten years of clinical drug development experience
• Industry experience required
• Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies of small molecules
• Experience and understanding of clinical trial data monitoring and all aspects of drug development
• Knowledge of GCP and ICH guidelines
• Leadership and Management experience highly desirable

Personal Strengths

• A proven self-starter and team player with strong interpersonal skills who establishes and nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Possess strong organizational skills and conflict resolution abilities
• Deep experience and knowledge in oncology clinical development

Education

• Not specified in the provided content