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Senior Scientific Director, Clinical Development

Remote

Position Summary

The Senior Scientific Director, Clinical Development is a senior scientific leader responsible for shaping and executing the clinical strategy for programs across late‑stage development and registration. This role integrates deep scientific expertise, strategic program leadership, and hands‑on clinical trial oversight to drive high‑quality data generation and advance assets toward regulatory approval.

The Scientific Director will serve as the scientific lead for key clinical studies, oversee protocol development and execution, guide data interpretation, contribute to global regulatory submissions, and partner cross‑functionally to influence clinical, regulatory, and operational decisions. This role requires significant experience in late‑stage development and direct contribution to NDA/BLA filings.

Key Responsibilities

  1. Clinical Strategy & Program Leadership
  • Lead the scientific strategy for one or more clinical programs, ensuring alignment with disease biology, commercial landscape, patient needs, and regulatory expectations.
  • Contribute to target product profiles (TPPs) and clinical development plans (CDPs).
  • Serve as the senior scientific representative on program teams, influencing decisions on all aspects of clinical development
  • Provide scientific leadership to ensure clinical program objectives, study designs, and data packages support regulatory and commercial success.
  1. Study Design & Protocol Development
  • Drive the design of scientifically rigorous late‑stage clinical trials, including pivotal/registrational studies.
  • Author or oversee development of protocols, amendments, investigator brochures, and informed consent forms.
  • Provide scientific rationales for endpoints, population selection, and statistical approaches in partnership with biostatistics.
  • Ensure consistency in study methodology, scientific integrity, and alignment with global clinical and regulatory strategy.
  1. Study Execution & Scientific Oversight
  • Serve as the scientific lead during trial execution, providing direction to internal teams, investigators, and CRO partners.
  • Participate in investigator meetings, site initiation activities, and relevant monitoring discussions.
  • Lead scientific and medical data review, integrating safety, efficacy, biomarker, and PK/PD data.
  • Address protocol‑related questions and support clinical operations in ensuring high study quality.
  1. Regulatory Leadership & Submissions
  • Contribute to global regulatory submissions including IND amendments, clinical study reports (CSRs), and modules for NDAs/BLAs. 
  • Author or review clinical summaries, briefing packages, and responses to health authority questions.
  • Support preparation for regulatory meetings and, when appropriate, participate in discussions with FDA, EMA, or other global agencies.
  • Ensure all clinical development activities are conducted in compliance with ICH/GCP and relevant international regulations.
  1. Data Interpretation & Scientific Communications
  • Synthesize complex clinical and scientific data into clear, actionable insights for governance, regulatory interactions, and publications.
  • Collaborate with biostatistics and data management on analysis plans, interpretation of interim and final data, and database lock preparation.
  • Contribute to abstracts, manuscripts, presentations, and key scientific communications for internal and external audiences.
  1. Cross‑Functional Collaboration & Leadership
  • Partner closely with Medical Directors, Clinical Operations, Regulatory Affairs, Drug Safety/PV, and Biostatistics to drive program execution.
  • Serve as a subject matter expert (SME) for clinical science across the organization, providing scientific guidance and decision support.

Qualifications

Required

  • Advanced scientific or medical degree (PhD, PharmD, MD, or equivalent).
  • 10+ years of clinical development experience, including direct ownership of late‑stage clinical trials and hands‑on NDA/BLA filing experience.
  • Proven leadership in designing, executing, and interpreting data from registrational studies.
  • Comprehensive understanding of clinical research methodology, GCP, and global regulatory expectations.
  • Demonstrated ability to integrate complex clinical, biomarker, and safety data into strategic recommendations.
  • Exceptional written and verbal communication skills, with experience developing scientific and regulatory documentation.

Preferred

  • Expertise in a relevant therapeutic area (oncology, cardiology, endocrinology, neurology, rare disease, etc.).
  • Experience interacting with FDA/EMA and presenting in regulatory or advisory forums.
  • Track record of scientific publications or conference presentations.

 

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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