Job Description
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, combined with the opportunity to lead and mentor cross-functional teams. The successful candidate will collaborate and partner with cross-functional subject matter experts across our company and site footprint 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 that 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.
Key responsibilities include:
- Strategic Leadership: Will oversee development of an array of early pipeline assets including IO targets, ADCs, TCEs and small molecules. Ability to mentor reports and represent programs 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., and present data to Pipeline Governance and senior management. Must additionally be able to evaluate new compound opportunities for BD/acquisitions understanding risks and opportunities.
- Clinical Development Plan (CDP): Developing and executing end-to-end clinical plans, including Phase 1/2 trial design, IND submissions, and Investigator Brochures.
- Cross-functional Collaboration: Partnering with Discovery Organization, Translational Medicine, Clinical pharmacology, Regulatory, and Operations teams to ensure fast and effective trial execution.
- Scientific & Medical Expertise: Analyzing patient data, including PK/PD modeling and biomarkers to optimize dosing and compound strategy.
- Talent Management: Mentoring and providing feedback to clinical team members and scientists to build high-performing teams.
- External outreach and leadership: Stays abreast of professional information, industry trends, and emerging technology through conferences, medical literature, and other available training, to augment expertise in drug development and the pharmaceutical industry. Works with team members to maintain a comprehensive and up-to-date understanding of the competitive environment in the field and to assess for potential impact on ongoing programs.
Education:
- MD, MD/PhD, with a strong background in oncology and early drug development.
Required Experience and Skills:
- 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 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
Required 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
Preferred Skills:
