Senior Principal Scientist (Senior Director), Clinical Research, ADC
Merck
13 days ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Role Responsibilities
- Evaluate pre-clinical/translational work to generate early clinical development plans and INDs
- Develop clinical development strategies
- Plan clinical trials (design and operational planning)
- Provide medical oversight and overall conduct of ongoing/new clinical trials, including dose optimization
- Analyze/summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publication
- Participate in internal and joint internal/external research project teams
- Work with tumor teams (PDTs) to transition drugs to registrational studies
- Support business development assessments of external opportunities
Additional Responsibilities (The Senior Director May)
- Engage with other functional areas to support study execution
- Work with cross-functional experts (commercialization, regulatory, statistics, manufacturing) to manage projects
- Support leadership by keeping appropriate personnel informed of study progress
- Provide expert opinion on scientific questions
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Experience in industry or as senior faculty in academia
- Minimum 3 years clinical medicine
- Minimum 3 years industry drug development (or biomedical research in academia)
- Demonstrated success overseeing clinical studies/protocols
- Record of scientific scholarship/achievement; proven clinical medicine and biomedical research background
- Strong interpersonal/team skills
Preferred Experience and Skills
- Board Certified or Eligible in Oncology (or related)
- Prior clinical research experience and prior publication
Required Skills
- Antibody Drug Conjugates (ADC), Clinical Development, Clinical Documentation, Clinical Medicine, Clinical Reporting, Clinical Trial Development, Clinical Trials, Drug Development, Ethical Standards, Oncology, Pharmaceutical Development, Regulatory Compliance, Regulatory Reporting, Strategic Planning
Application Instructions
- Apply through https://jobs.merck.com/us/en. (Application deadline is stated on the posting; Requisition ID: R394490.)
- Evaluate pre-clinical/translational work to generate early clinical development plans and INDs
- Develop clinical development strategies
- Plan clinical trials (design and operational planning)
- Provide medical oversight and overall conduct of ongoing/new clinical trials, including dose optimization
- Analyze/summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publication
- Participate in internal and joint internal/external research project teams
- Work with tumor teams (PDTs) to transition drugs to registrational studies
- Support business development assessments of external opportunities
Additional Responsibilities (The Senior Director May)
- Engage with other functional areas to support study execution
- Work with cross-functional experts (commercialization, regulatory, statistics, manufacturing) to manage projects
- Support leadership by keeping appropriate personnel informed of study progress
- Provide expert opinion on scientific questions
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Experience in industry or as senior faculty in academia
- Minimum 3 years clinical medicine
- Minimum 3 years industry drug development (or biomedical research in academia)
- Demonstrated success overseeing clinical studies/protocols
- Record of scientific scholarship/achievement; proven clinical medicine and biomedical research background
- Strong interpersonal/team skills
Preferred Experience and Skills
- Board Certified or Eligible in Oncology (or related)
- Prior clinical research experience and prior publication
Required Skills
- Antibody Drug Conjugates (ADC), Clinical Development, Clinical Documentation, Clinical Medicine, Clinical Reporting, Clinical Trial Development, Clinical Trials, Drug Development, Ethical Standards, Oncology, Pharmaceutical Development, Regulatory Compliance, Regulatory Reporting, Strategic Planning
Application Instructions
- Apply through https://jobs.merck.com/us/en. (Application deadline is stated on the posting; Requisition ID: R394490.)