Translational Medicine Clinical Operations Immunology Therapeutic Area Lead (Pri
Merck, Rahway, NJ, United States
Job Description
Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof‑of‑concept and advance the most promising candidates through the pipeline to patients. We design and execute clinical pharmacology strategies spanning first‑in‑human studies through proof‑of‑biology/proof‑of‑concept and into late‑stage development, supporting worldwide marketing applications and lifecycle management.
Key Responsibilities
Co‑own and execute the early 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 ensure efficient, timely execution against milestones.
Ensure appropriate resources, competencies, and partnerships are in place to meet objectives.
Serve as the deep subject‑matter expert for early immunology clinical operations.
Critically review strategy and clinical program documents (development plans, investigator’s brochures, protocols, etc.), providing scientific and operational insight to ensure the 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 the 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 a “player‑coach” to enrich group skillsets. Potential for people management.
Represent TMed on enterprise strategic initiatives and lead continuous‑improvement efforts that increase program efficiency and scientific impact.
Serve as a member of the TMed U.S. 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 + ≥12 years related experience, or
Master’s degree + ≥10 years related experience, or
Ph.D. or doctorate + ≥8 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
Proven track record building and leading high‑performing cross‑functional teams in a matrixed environment.
Deep knowledge of early clinical development (Phase 1 and early proof‑of‑concept).
Demonstrated ability to collaborate, network, and influence peers, senior leaders, and external partners.
Strong oral and written communication skills.
Track record delivering results on firm deadlines.
Strong decision‑making skills, weighing advantages, disadvantages, and business impact for rapid decisions.
Ability to work successfully with ambiguity and embrace uncertainty.
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.
Location Requirements
US and Puerto Rico residents only.
Salary
$190,800.00 – $300,300.00.
Benefits
We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.
EEO Statement
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 applicable 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 Opportunity Employment laws, visit the EEOC sites listed below.
Links
EEOC Know Your Rights
EEOC GINA Supplement
#J-18808-Ljbffr
Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof‑of‑concept and advance the most promising candidates through the pipeline to patients. We design and execute clinical pharmacology strategies spanning first‑in‑human studies through proof‑of‑biology/proof‑of‑concept and into late‑stage development, supporting worldwide marketing applications and lifecycle management.
Key Responsibilities
Co‑own and execute the early 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 ensure efficient, timely execution against milestones.
Ensure appropriate resources, competencies, and partnerships are in place to meet objectives.
Serve as the deep subject‑matter expert for early immunology clinical operations.
Critically review strategy and clinical program documents (development plans, investigator’s brochures, protocols, etc.), providing scientific and operational insight to ensure the 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 the 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 a “player‑coach” to enrich group skillsets. Potential for people management.
Represent TMed on enterprise strategic initiatives and lead continuous‑improvement efforts that increase program efficiency and scientific impact.
Serve as a member of the TMed U.S. 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 + ≥12 years related experience, or
Master’s degree + ≥10 years related experience, or
Ph.D. or doctorate + ≥8 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
Proven track record building and leading high‑performing cross‑functional teams in a matrixed environment.
Deep knowledge of early clinical development (Phase 1 and early proof‑of‑concept).
Demonstrated ability to collaborate, network, and influence peers, senior leaders, and external partners.
Strong oral and written communication skills.
Track record delivering results on firm deadlines.
Strong decision‑making skills, weighing advantages, disadvantages, and business impact for rapid decisions.
Ability to work successfully with ambiguity and embrace uncertainty.
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.
Location Requirements
US and Puerto Rico residents only.
Salary
$190,800.00 – $300,300.00.
Benefits
We offer a comprehensive package of benefits including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.
EEO Statement
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 applicable 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 Opportunity Employment laws, visit the EEOC sites listed below.
Links
EEOC Know Your Rights
EEOC GINA Supplement
#J-18808-Ljbffr