Director, Clinical Science

United StatesRemoteFull-timeexecutive

OtherDirector

2 views0 saves0 applied

Apply Now

Quick Summary

Overview

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.

Technical Tools

OtherDirector

This leadership role supports the development and lifecycle management of innovative therapies for patients living with rare diseases, with a focus on nephrology.
You will contribute scientific and clinical expertise across the design, execution, analysis, and reporting of clinical development programs.
The position works closely with multidisciplinary teams spanning clinical development, clinical pharmacology, biostatistics, regulatory, and external partners.
You will help translate complex clinical and translational data into meaningful insights that inform development strategy and regulatory submissions.
The role offers significant involvement in protocols, clinical reports, regulatory documents, scientific publications, and presentations.
You will also build relationships with investigators, key opinion leaders, alliance partners, and other external stakeholders.
This is a collaborative, fast-paced environment for a scientifically driven leader motivated by improving outcomes for patients with rare diseases.

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.

Requirements

~2 min read

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.