Merck & Co, Inc

Sr. Principal Scientist, Clinical Operations Immunology Lead

Merck & Co, Inc$210K — $331K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree with 16+ years or Master's degree with 15+ years or PhD/PharmD with 12+ years of related experience
  • Extensive experience in early clinical trial operations, particularly Phase 1
  • Strong decision-making aptitude under ambiguity
  • Proven ability to build and lead cross-functional teams
  • Expertise in communicating with diverse stakeholders across various levels
  • Experience in mentoring and developing talent

Responsibilities

  • Co-own and execute early clinical development strategy for the immunology portfolio
  • Provide strategic planning and operational oversight for clinical trials
  • Build a global network with immunology sites and key trial investigators
  • Serve as a subject matter expert for early clinical operations
  • Review and critique clinical program documents to enhance strategic direction
  • Partner with Business Development to assess alignment of opportunities
  • Participate in annual and quarterly planning cycles to mitigate risks

Benefits

  • Flexible hybrid work arrangements
  • Opportunities for professional growth and mentorship
  • Exposure to cutting-edge immunology clinical programs
  • Strong cross-functional collaboration across diverse teams
  • Participation in enterprise strategic initiatives for clinical efficiency
Full Job Description
Job Description

In a competitive external landscape and fast-paced internal environment, the Immunology Clinical Operations Lead position provides both strategic and operational leadership across early immunology programs, ensuring timely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide. The successful candidate will telescope between strategy and hands-on execution across a portfolio of diverse modalities (e.g. peptides, small molecules, biologics), and partner cross-functionally to develop the needed expertise to successfully advance programs to key inflection points in development. This role is equivalent in level to a Senior Director position.

Key Responsibilities:
  • Co-own and execute the early clinical development strategy for the immunology portfolio with the Head of TMed Immunology
  • Provide comprehensive strategic planning and operational oversight for immunology clinical programs and trials to maximize operational feasibility, efficiency, and ensure consistency and quality across the portfolio
  • Build global network of immunology sites and foster relationships with key investigators for Ph1b/2a patient trials to deliver on clinical program goals
  • Serve as the deep subject matter expert and issue escalation point for early immunology clinical operations
  • Ensure appropriate resources, competencies, and partnerships are in place to meet objectives
  • Critically review strategy and clinical program documents (development plans, investigator's brochures, protocols, etc.), providing scientific and operational insight to ensure best path forward
  • Partner with Business Development and Licensing to evaluate internal and external opportunities that align with portfolio strategy
  • Actively participate in annual and quarterly planning cycles: identify risks, develop and execute mitigation plans, and track performance metrics and outcomes
  • Ensure immunology data integrity across organization (Book of Business, CTMS, etc.)
  • Build and sustain strong cross-functional relationships (country operations, clinical supplies, data management, regulatory, etc.) across departments, divisions, and geographies
  • Foster the people pipeline: Attract, coach, mentor, and retain talent; provide performance management support; act as 'player-coach' to enrich group skillsets. Potential for people management.
  • Represent TMed on enterprise strategic initiatives and lead continuous-improvement efforts that increase clinical efficiency and scientific impact
  • Serve as a member of the TMed Clinical Operations leadership team and contribute to shaping department strategy


Education Requirement
  • Degree in Life Sciences with one of the following experience combinations:
  • Bachelor's degree + 6gt;=16 years related experience, OR
  • Master's degree + 6gt;=15 years related experience, OR
  • PhD/PharmD + 6gt;=12 years related experience
  • Related Experience Includes: pharmaceutical industry roles in clinical drug development, clinical trial management, clinical site monitoring/training, medical/regulatory writing, or translational science


Required Experience and Skills
  • Extensive clinical operations experience in the planning and execution of early clinical development trials (Phase 1 and early proof-of-concept)
  • Demonstrated ability to translate knowledge to other areas to effectively collaborate, network, and influence peers, senior leaders, and external partners
  • Proven track record building and leading high-performing cross-functional teams in a matrixed environment
  • Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions and proven track record delivering results on firm deadlines
  • Ability to work successfully with ambiguity and embrace uncertainty
  • Strong oral and written communication skills
  • Experience attracting, developing, and retaining talent


Preferred Experience and Skills
  • Experience leading clinical programs and trials for gastroenterology, dermatology, and/or rheumatology, especially autoimmune or immune-mediated disorders, including in both large and small pharma contexts
  • Familiarity with broader pharmaceutical industry considerations and trends beyond clinical development


#EligibleforERP

Required Skills:
Clinical Development, Clinical Research, Clinical Studies, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Operations, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Early Clinical Development, Early Phase Clinical Trials, Ethical Compliance, Ethical Standards, External Partners, Mentorship, Operational Leadership, Professional Networking, Protocol Development, Translational Medicine

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/a

Job Posting End Date:
07/31/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ

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