The Clinical Research Department is searching for an experienced clinical scientist.
The Clinical Scientist will act as either the clinical program or clinical study lead in conjunction with the medical directors in order to implement the strategic and operational clinical research.
- Provide scientific support by interpreting safety and efficacy results in clinical trials, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Contribute to the organization, preparation, and execution of investigator and advisory board meetings.
- Contribute to the authoring and revision of regulatory submissions.
- Contribute to drafting manuscripts, review and summarize relevant literature.
- A PharmD, PhD, or PA with at least 5 years of experience in planning, executing, reporting and/or publishing clinical studies.
- Good understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills.
- Effective oral and written communication skills and the ability to influence, negotiate, and communicate with project team.
- Ability to work collaboratively in a fast-paced, team-based matrix environment.
- Prior clinical research experience in these therapeutic areas: GI, endocrinology, metabolic diseases, rare diseases or CNS.
- Ability to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.