Scientific AVP, Clinical Research, Oncology Early Development

Overview

We are searching for a Section Lead to join Oncology Early Development (OED). This is an opportunity to oversee clinical strategy for one third of our company's early development internal pipeline, and to lead and mentor cross-functional teams. The successful candidate will collaborate with cross-functional subject matter experts and be accountable for advancement of programs from candidate stage to clinical proof of concept milestones.

A Section Lead in Oncology Early Development oversees 3-5 direct reports who are medical directors and/or Early Development team leads. Section leads supervise cross-functional teams to advance oncology assets from preclinical stages to clinical proof-of-concept. They draw on significant expertise to define clinical and translational strategies, oversee timelines and risks, and interpret data to inform go/no-go decisions.

• Strategic Leadership: Oversee development of an array of early pipeline assets including IO targets, ADCs, TCEs and small molecules. Mentor reports and represent programs at senior management and governance forums. Experience in safety assessment for phase 1 designs, characterization of exploratory and selection biomarkers, and dose finding for new compounds; present data to Pipeline Governance and senior management. Evaluate new compound opportunities for BD/acquisitions, understanding risks and opportunities.
• Clinical Development Plan (CDP): Develop and execute end-to-end clinical plans, including Phase 1/2 trial design, IND submissions, and Investigator Brochures.
• Cross-functional 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 and Leadership: Stay abreast of professional information, industry trends, and emerging technology; augment expertise in drug development and the pharmaceutical industry. Maintain a comprehensive and up-to-date understanding of the competitive environment and assess potential impact on ongoing programs.

• MD, MD/PhD, with a strong background in oncology and early drug development.

• 10+ years of industry experience required. Preferably, at least 5 years of experience 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 design of study protocols.
• Strong scientific background in oncology drug development (basic, translational and/or clinical); experience in development of multiple mechanisms of action (e.g. small molecules, biologics including ADCs and TCEs), and 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.
• Ability to lead and manage through influence; delegate 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 to assess opportunities, options, risks, and mitigations.
• Demonstrated commitment to training and development of junior-level staff, with autonomy appropriate to their level.
• 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.

Change Management, Clinical Pharmacology, Clinical Strategy, Clinical Trial Development, Consulting, Ethical Standards, Executive Presence, Immunology, Innovation, Interpersonal Relationships, Ophthalmology, Professional Networking, Results-Oriented, Translational Medicine, Vaccine Development

Current Employees apply HERE

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal…