Director, Clinical Science
New
J
JobgetherPharmaceutical, rare disease
Remote work opportunity in the United StatesFull-TimeDirector
SalaryTarget base salary range of $206,000–$268,000
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Job Details
- Experience
- 6+ years of pharmaceutical industry experience
Requirements
- PhD, PharmD, and/or MD in a relevant life science or healthcare discipline.
- 6+ years of pharmaceutical industry experience; equivalent combinations of education and relevant academic or professional experience are considered.
- Demonstrated experience working on clinical trials and clinical studies.
- Experience with human pharmacology studies is preferred.
- Experience in rare disease and/or nephrology is strongly preferred.
- Experience contributing to regulatory submissions such as INDs, NDAs, and BLAs, and responses to regulatory information requests, is highly desirable.
- Strong scientific expertise and ability to review, interpret, and communicate complex clinical and scientific data.
- Strong written, verbal, and presentation skills for communicating with scientific, clinical, regulatory, and business stakeholders.
- Ability to manage multiple priorities in a dynamic, cross-functional environment.
- Willingness and ability to travel approximately 15% domestically and internationally.
Responsibilities
- Support the design, implementation, and oversight of clinical studies, including human pharmacology studies where applicable.
- Analyze, interpret, and report clinical data, focusing on safety and efficacy outcomes.
- Collaborate with multidisciplinary study teams to ensure clinical activities follow Good Clinical Practice standards.
- Provide scientific leadership for clinical reports, data analysis reports, presentations, trial registry summaries, and other development deliverables.
- Contribute to regulatory submissions and interactions, including INDs, NDAs, BLAs, and responses to regulatory information requests.
- Develop clinical and scientific rationales, benefit-risk assessments, efficacy and safety summaries, and mechanism-of-action content.
- Build and maintain relationships with alliance partners, investigators, external organizations, and key opinion leaders.
- Translate complex scientific and clinical data into presentations and strategic recommendations.
- Prepare scientific manuscripts and contribute to medical and scientific conference presentations.
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