Associate Director, Clinical Scientist
Position Summary
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Reporting to the Executive Director of Clinical Development, the Associate Director, Clinical Scientist will provide scientific input to early-stage clinical development programs.
The Associate Director, Clinical Scientist will be responsible for the review of patient data, they will give input on clinical trial design, and will aid in preparation of data for presentation to leadership, at conferences, and to safety oversight committees.
Responsibilities
Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.
g., protocols, investigators brochure, eCRFs, ICFs, CSRs)
- Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
- Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
- Assist in communicating a clear overview of trial results
- Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
- Review and synthesize scientific literature and competitive intelligence to support study and program strategy
- Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
- Support preparation of scientific material for conference presentations or publications
- Contribute to the authoring and revision of regulatory submissions
- Perform analyses and generate scientific slide decks based on clinical, translational and other datasets
Minimum Qualifications
- PhD, RN, or NP with 5+ years of significant experience as a Clinical Scientist in a biopharmaceutical organization
- Prior experience as a Clinical Scientist in an industry setting
- Excellent oral and written communication skills and analytical skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
Preferred Qualifications
- MD with 3-5+ years of biopharmaceutical experience
- Experience in genetic medicines
- Prior work on cardiovascular trials or cardiovascular clinical experience
- Clinical cardiovascular experience
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