Scientific AVP, Clinical Research, Oncology Early Development

Merck • Rahway, NJ

1d • $342,800 - $539,600 • Hybrid

About The Position

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.

Requirements

• 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 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.
• Excellent oral and written communication skills

Nice To Haves

• 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

Responsibilities

• Oversee development of an array of early pipeline assets including IO targets, ADCs, TCEs and small molecules.
• Mentor reports and represent programs to 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.
• Developing and executing end-to-end clinical plans, including Phase 1/2 trial design, IND submissions, and Investigator Brochures.
• Partnering with Discovery Organization, Translational Medicine, Clinical pharmacology, Regulatory, and Operations teams to ensure fast and effective trial execution.
• Analyzing patient data, including PK/PD modeling and biomarkers to optimize dosing and compound strategy.
• Mentoring and providing feedback to clinical team members and scientists to build high-performing teams.
• Staying 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.
• Oversee multiple complex clinical research programs.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior