Job Description
Job Summary
This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team.
Job Responsibilities
Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
- 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.
Other responsibilities include:
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
- 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.
Core Skills
- 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 conclusions.
- Interact with key stakeholders across department, division, and company.
- Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
- Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
- Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
- Problem solving, prioritization, conflict resolution, and critical thinking skills.
- Build team capabilities through proactive coaching.
- Strong communication, technical writing, and presentation skills.
Experience
- Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
- Master’s + 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
- PhD / PharmD.
- Degree in life sciences, preferred.
Ideal candidate would have
- Experience in conducting global clinical trials, including trial initiation through database lock.
- Experience in conducting clinical trials in gastrointestinal, rheumatologic and/or dermatologic disorders preferably autoimmune/immune mediated disease trials.
- Experience with external expert review of participant eligibility (e.g., QC inclusion and exclusion criteria).
Candidates with the following experiences/expertise are preferred, but not required
- 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.
#J-18808-Ljbffr
