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:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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