Director, Clinical Science

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Science based in the United States.

• Support the design, implementation, and oversight of clinical studies, including human pharmacology studies where applicable.
• Contribute to clinical data analysis, interpretation, and reporting, with a focus on evaluating safety and efficacy outcomes.
• Collaborate with multidisciplinary study teams to ensure clinical activities are conducted in accordance with Good Clinical Practice (GCP) standards.
• Provide scientific leadership for clinical reports, data analysis reports, presentations, clinical trial registry summaries, and other development deliverables.
• Contribute to regulatory submissions and interactions, including INDs, NDAs, BLAs, regulatory briefing materials, investigator brochures, protocols, statistical analysis plans, mock tables/listings/figures, and responses to regulatory information requests.
• Support the development of clinical and scientific rationales, benefit-risk assessments, efficacy and safety summaries, and mechanism-of-action content.
• Establish and maintain productive relationships with alliance partners, investigators, external organizations, and key opinion leaders to advance clinical programs and collaborations.
• Interpret complex scientific and clinical data and translate findings into clear presentations and strategic recommendations.
• Prepare scientific manuscripts and contribute to presentations at medical and scientific conferences.
• Work collaboratively with internal and external stakeholders to advance clinical development priorities and adapt strategies as programs evolve.

• PhD, PharmD, and/or MD in a relevant life science or healthcare discipline.
• 6+ years of pharmaceutical industry experience, with equivalent combinations of education and relevant academic or professional experience 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, as well as responses to regulatory information requests, is highly desirable.
• Strong scientific expertise and the ability to review, interpret, and communicate complex clinical and scientific data.
• Excellent organizational skills, attention to detail, and the ability to manage multiple priorities in a dynamic, cross-functional environment.
• Strong written, verbal, and presentation skills, with the ability to communicate effectively with scientific, clinical, regulatory, and business stakeholders.
• Demonstrated ability to collaborate effectively within multidisciplinary teams and foster an inclusive environment built on open dialogue and creative problem solving.
• Ability to adapt to changing project plans, priorities, strategies, and development requirements.
• Strong interpersonal skills and the ability to establish effective relationships with investigators, key opinion leaders, external partners, and internal stakeholders.
• Passion for advancing therapies and improving outcomes for people living with rare diseases.
• Willingness and ability to travel approximately 15% domestically and internationally.

• Target base salary range of $206,000–$268,000, with actual compensation determined by experience, education, skills, and location.
• Short-term incentive compensation opportunities.
• Long-term incentive compensation, including company stock.
• Premium health benefits for eligible employees and dependents.
• Financial and retirement benefits, including a retirement plan with employer matching.
• Life insurance and disability coverage.
• Generous paid time off.
• Work-life and well-being programs.
• Wellness and employee support resources.
• Opportunity to contribute to clinical development programs addressing significant unmet needs in rare disease.
• Collaborative, multidisciplinary working environment with opportunities to engage with leading scientific and clinical experts.
• Remote work opportunity in the United States, with approximately 15% travel as required.
• Applications are accepted on an ongoing basis until the position is filled.