Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology
Merck
12 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Strategically plan and direct clinical research for investigational compounds in Immunology, with focus on late-stage development.
- Manage the full clinical development cycle: select disease indications, design studies, initiate, execute, monitor, analyze, support regulatory filings, and publication.
- Evaluate pre-clinical and translational work to create early clinical development plans and support Investigational New Drug (IND) applications.
- Provide clinical development support for business development assessments of external opportunities.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage ongoing and new clinical trials.
- Analyze and 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.
Supervision/Collaboration:
- Supervise Clinical Scientists executing clinical studies.
- Work with cross-functional teams (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Maintain scientific knowledge by tracking developments, identifying strong investigators, building external collaborations (e.g., Rheumatology, Gastroenterology, Dermatology, Pulmonary, rare diseases), and attending scientific meetings.
Qualifications:
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience: Phase 2/3 Immunology trial design/execution; 3+ years clinical medicine; 5+ years industry drug development.
- Demonstrated scientific scholarship; strong interpersonal skills and cross-functional collaboration.
Required skills: Clinical Development; Clinical Documentation; Clinical Immunology; Clinical Judgment; Clinical Medicine; Clinical Research Management; Clinical Sciences; Clinical Studies; Clinical Trial Development; Data Analysis; Drug Development; Hiring; Ophthalmology; Rare Diseases; Scientific Consulting; Strategic Planning.
Travel: ~20%.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Strategically plan and direct clinical research for investigational compounds in Immunology, with focus on late-stage development.
- Manage the full clinical development cycle: select disease indications, design studies, initiate, execute, monitor, analyze, support regulatory filings, and publication.
- Evaluate pre-clinical and translational work to create early clinical development plans and support Investigational New Drug (IND) applications.
- Provide clinical development support for business development assessments of external opportunities.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage ongoing and new clinical trials.
- Analyze and 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.
Supervision/Collaboration:
- Supervise Clinical Scientists executing clinical studies.
- Work with cross-functional teams (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Maintain scientific knowledge by tracking developments, identifying strong investigators, building external collaborations (e.g., Rheumatology, Gastroenterology, Dermatology, Pulmonary, rare diseases), and attending scientific meetings.
Qualifications:
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience: Phase 2/3 Immunology trial design/execution; 3+ years clinical medicine; 5+ years industry drug development.
- Demonstrated scientific scholarship; strong interpersonal skills and cross-functional collaboration.
Required skills: Clinical Development; Clinical Documentation; Clinical Immunology; Clinical Judgment; Clinical Medicine; Clinical Research Management; Clinical Sciences; Clinical Studies; Clinical Trial Development; Data Analysis; Drug Development; Hiring; Ophthalmology; Rare Diseases; Scientific Consulting; Strategic Planning.
Travel: ~20%.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).