Scientific AVP, Clinical Research, Oncology Early Development

Key Responsibilities

• Strategic Leadership: Oversee development of an array of early pipeline assets including IO targets, ADCs, TCEs and small molecules. Mentor reports and represent programs senior management and governance forums.
• Experience in Safety Assessment: Conduct safety assessments for phase 1 designs, characterize exploratory and selection biomarkers, and dose finding for new compounds. Present data to Pipeline Governance and senior management.
• Evaluating New Compound Opportunities: Evaluate new compound opportunities for Business Development/Acquisitions, understanding risks and opportunities.
• Developing and Executing CDP: Develop and execute end-to-end clinical plans, including Phase 1/2 trial design, IND submissions, and Investigator Brochures.
• Collaboration: Partner with Discovery Organization, Translational Medicine, Clinical Pharmacology, Regulatory, and Operations teams to ensure fast and effective trial execution.
• Scientific & Medical Expertise: Analyze patient data, including PK/PD modeling and biomarkers to optimize dosing and compound strategy.
• Talent Management: Mentor and provide feedback to clinical team members and scientists to build high-performing teams.
• External Outreach: Stay updated on professional information, industry trends, and emerging technology through conferences, medical literature, and other training to augment expertise in drug development and the pharmaceutical industry. Support a global scientific and business strategy.
• Overseeing Programs: Oversee multiple complex clinical research programs.
• Communication: Excellent oral and written communication skills.

Required Experience And Skills

• 10+ years of industry experience, preferably 5 years in oncology early development.
• In-depth knowledge of early development/phase 1 clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Strong scientific background in oncology drug development (basic, translational and/or clinical); and experience in the development of multiple mechanisms of action (e.g. small molecules, biologics including ADCs and TCEs), experience in design and conduct of oncology early clinical trials.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence. Ability to delegate appropriate accountability and decision-making to support teams and functions.
• Strong collaboration, facilitative leadership, executive function, and problem-solving skills. Ability and willingness to respectfully challenge team members and functions in order to assess fully all opportunities, options, risks, and mitigations.
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Ability to oversee multiple complex clinical research programs.
• Excellent oral and written communication skills.