Clinical Director (Principal Scientist), Translational Medicine, Immunology
Merck
13 days ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Translational Medicine (Immunology) Principal Scientist/Medical Director–level role.
Translational Medicine is responsible for early clinical development of novel therapeutics.
Responsibilities:
- Lead early clinical development strategy from Preclinical Candidate approval through Clinical Pharmacology (Phase 1) and clinical Proof-of-Concept (Phase 2).
- Develop biomarker strategies via cross-functional teams, from First-in-Human through Proof-of-Concept; include Experimental Medicine to establish/validate biomarker platforms.
- Partner with discovery research to incorporate clinical perspective into target identification/validation; execute clinical studies to evaluate target relevance to human disease.
- Develop and execute clinical pharmacology strategies to support Proof-of-Concept (Phase 2) through worldwide marketing application.
- Serve as a key member of an early development team; design and execute early clinical development strategy.
- Author initial clinical and biomarker plans (Lead Optimization), early clinical development plans (Preclinical Candidate molecules), and clinical pharmacology studies (Phases I–IV).
- Validate clinical platforms using established/novel biomarkers (imaging, electrophysiological, and behavioral responses in humans).
- Provide clinical expertise for target/pathway validation (preclinical and/or clinical pharmacology experiments).
- Ensure safe, timely Phase I execution; collaborate with discovery research, biostatistics, drug metabolism, modeling/simulation, regulatory affairs, and global clinical trials operations.
- Support submissions for worldwide marketing application filings (registration documents and presentations).
- Communicate and interpret study results to governance/expert groups and development review committees.
- Interface broadly with Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations/EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research.
Education: MD or MD/PhD.
Required:
- Proven track record in clinical medicine or clinical research; background in biomedical research.
- Demonstrated scientific scholarship (publications/presentations); collaborative mindset across therapeutic areas.
- Strong interpersonal, writing, and presentation skills.
Preferred:
- Clinical Board Certification or eligibility.
- Experience in translational research and/or early clinical development (preferred).
- Proven track record in clinical care or management of clinical problem-solving.
Required skills: Clinical Development, Clinical Judgment, Clinical Research/Studies/Trials, Clinical Trial Support, Cross-Functional Teamwork, Early Clinical Development, Immunology, Intellectual Curiosity, Translational Medicine, Translational Research.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Translational Medicine is responsible for early clinical development of novel therapeutics.
Responsibilities:
- Lead early clinical development strategy from Preclinical Candidate approval through Clinical Pharmacology (Phase 1) and clinical Proof-of-Concept (Phase 2).
- Develop biomarker strategies via cross-functional teams, from First-in-Human through Proof-of-Concept; include Experimental Medicine to establish/validate biomarker platforms.
- Partner with discovery research to incorporate clinical perspective into target identification/validation; execute clinical studies to evaluate target relevance to human disease.
- Develop and execute clinical pharmacology strategies to support Proof-of-Concept (Phase 2) through worldwide marketing application.
- Serve as a key member of an early development team; design and execute early clinical development strategy.
- Author initial clinical and biomarker plans (Lead Optimization), early clinical development plans (Preclinical Candidate molecules), and clinical pharmacology studies (Phases I–IV).
- Validate clinical platforms using established/novel biomarkers (imaging, electrophysiological, and behavioral responses in humans).
- Provide clinical expertise for target/pathway validation (preclinical and/or clinical pharmacology experiments).
- Ensure safe, timely Phase I execution; collaborate with discovery research, biostatistics, drug metabolism, modeling/simulation, regulatory affairs, and global clinical trials operations.
- Support submissions for worldwide marketing application filings (registration documents and presentations).
- Communicate and interpret study results to governance/expert groups and development review committees.
- Interface broadly with Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations/EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research.
Education: MD or MD/PhD.
Required:
- Proven track record in clinical medicine or clinical research; background in biomedical research.
- Demonstrated scientific scholarship (publications/presentations); collaborative mindset across therapeutic areas.
- Strong interpersonal, writing, and presentation skills.
Preferred:
- Clinical Board Certification or eligibility.
- Experience in translational research and/or early clinical development (preferred).
- Proven track record in clinical care or management of clinical problem-solving.
Required skills: Clinical Development, Clinical Judgment, Clinical Research/Studies/Trials, Clinical Trial Support, Cross-Functional Teamwork, Early Clinical Development, Immunology, Intellectual Curiosity, Translational Medicine, Translational Research.
Application instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).