Senior Clinical Scientist – Immunology
| Company | Merck |
|---|---|
| Location | North Wales, PA, USA, Linden, NJ, USA |
| Salary | $114700 – $180500 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD |
| Experience Level | Senior |
Requirements
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multiple competing priorities with good planning, time management and prioritization skills
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusion
- Strong communication, technical writing, and presentation skills
- Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master’s + 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD / PharmD.
Responsibilities
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s)
- Serving as the lead clinical scientist on the clinical trial team
- Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments)
- Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct
- Providing tactical/scientific mentorship to other clinical scientists
Preferred Qualifications
- Experience in conducting global clinical trials, including trial initiation through database lock
- Experience in conducting clinical trials in rheumatologic disorders, preferably autoimmune/immune mediated disease trials
- Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria)
- Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee
- Managing other scientists directly supporting the clinical trial