Associate Principal Scientist, Clinical Operations – Immunology
MSD
full-time
Posted on:
Location Type: Hybrid
Location: North Wales • California • New Jersey • United States
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Salary
💰 $142,400 - $224,100 per year
About the role
- This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies
- Under the direction of the Program Lead, you will collaborate with global, cross functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.
- Responsible for the clinical/scientific execution of clinical protocol(s)
- Serves as the lead clinical scientist on the clinical trial team
- Collaborates with the Medical Writer on clinical/scientific and regulatory documents
- Partners with Study Manager on study deliverables
- Participates in the set up and design during study start up (e.g., database set up)
- Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director
- Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities
- May include management of direct reports including assignment of resources, professional development, and performance management.
- May serve as a subject matter expert and/or participate on process improvement teams.
Requirements
- Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Degree in life sciences, preferred
- Experience in conducting global clinical trials, including trial initiation through database lock
- Experience in developing protocols and study related documents for Immunology related clinical trials
- Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in Immunology related clinical trials
- Experience in performing medical monitoring in Immunology related clinical trials.
- Advanced communication, technical writing, and presentation skills.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
clinical trial executionprotocol developmentmedical monitoringdata reviewdatabase setupclinical data interpretationproject managementclinical drug developmentImmunology clinical trialsparticipant eligibility review
Soft Skills
collaborationcoachingmentoringcommunicationtechnical writingpresentation skillsleadershipteam buildingperformance managementprocess improvement