Senior Director, Clinical Development - Antibacterials, Antifungals, CMV & Covid 19
Merck
13 days ago
Remote
United States
Clinical Research and Development
Responsibilities:
- Own protocol development and medical/scientific oversight for infectious diseases clinical research studies (investigational/marketed drugs), mainly Phase 2–3.
- Support study design, medical monitoring, interpretation of analyses, regulatory reporting, and publication.
- Plan and execute clinical trials based on infectious disease clinical development strategies.
- Monitor and manage conduct of ongoing/new clinical trials.
- Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Lead cross-functional internal scientific efforts and provide external leadership with key scientific leaders.
- Present data and program strategic plans to internal governance committees.
- Maintain scientific expertise via ongoing awareness, investigator engagement, and attendance at scientific meetings.
Qualifications:
- MD or MD/PhD (preferred with infectious disease expertise); PharmD may be considered.
- Eligibility for medical licensure and board certification desirable.
- 5+ years industry experience in clinical research/drug development.
- Demonstrated success overseeing clinical studies/protocols; strong scientific scholarship.
- Experience in clinical medicine.
- Excellent verbal/written communication; strong interpersonal skills and leadership.
Preferred:
- Infectious diseases clinical research/drug development background.
- Experience with registrational trials and filings with major health authorities.
Required skills (examples): Clinical Development, Clinical Research Management, Clinical Trial Development/Compliance, Data Analysis, Drug Development, Protocol Development, Regulatory Compliance/Reporting, Scientific Publications, Strategic Planning.
Application instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub).
- Own protocol development and medical/scientific oversight for infectious diseases clinical research studies (investigational/marketed drugs), mainly Phase 2–3.
- Support study design, medical monitoring, interpretation of analyses, regulatory reporting, and publication.
- Plan and execute clinical trials based on infectious disease clinical development strategies.
- Monitor and manage conduct of ongoing/new clinical trials.
- Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Lead cross-functional internal scientific efforts and provide external leadership with key scientific leaders.
- Present data and program strategic plans to internal governance committees.
- Maintain scientific expertise via ongoing awareness, investigator engagement, and attendance at scientific meetings.
Qualifications:
- MD or MD/PhD (preferred with infectious disease expertise); PharmD may be considered.
- Eligibility for medical licensure and board certification desirable.
- 5+ years industry experience in clinical research/drug development.
- Demonstrated success overseeing clinical studies/protocols; strong scientific scholarship.
- Experience in clinical medicine.
- Excellent verbal/written communication; strong interpersonal skills and leadership.
Preferred:
- Infectious diseases clinical research/drug development background.
- Experience with registrational trials and filings with major health authorities.
Required skills (examples): Clinical Development, Clinical Research Management, Clinical Trial Development/Compliance, Data Analysis, Drug Development, Protocol Development, Regulatory Compliance/Reporting, Scientific Publications, Strategic Planning.
Application instructions:
- Apply at https://jobs.merck.com/us/en (or via the Workday Jobs Hub).