Executive Director, Clinical Research
Amicus Therapeutics
Senior Principal Scientist, Clinical Research, Immunology
MSD
full-time
Posted on:
Location Type: Hybrid
Location: California, Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $276,600 - $435,400 per year
Job Level
Senior
About the role
- Strategic planning and directing clinical research activities involving investigational compounds in Immunology
- Manage entire cycle of clinical development including indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication
- Evaluate pre-clinical and translational work to generate early clinical development plans and 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 conduct of ongoing or new clinical trials
- Analyze and summarize clinical findings to support safety, efficacy decisions, regulatory submissions, and publications
- Participate in internal and joint internal/external research project teams
- Supervise activities of Clinical Scientists (may)
- Collaborate with commercialization, regulatory affairs, statistics, and manufacturing teams
- Maintain scientific knowledge through attending scientific meetings and establishing external collaborations
- Author development documents, presentations, budgets, and position papers
- Travel on company business about 20% of the time to manage clinical research projects
Requirements
- M.D., D.O., M.D./PhD, or D.O./PhD
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology)
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment
- Required Skills: Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development, Clinical Trials, Dermatology, Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance, Rheumatology
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive (if applicable)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentclinical research managementclinical trial developmentphase 2 clinical trialsphase 3 clinical trialsIND applicationssafety analysisefficacy analysisregulatory submissionsscientific writing
Soft skills
interpersonal skillscollaborative teamworkstrategic planningsupervisioncommunication
Certifications
M.D.D.O.M.D./PhDD.O./PhD