Associate/ Director Clinical Science

Salary $220,000
LocationCambridge, Massachusetts
Employment type Permanent
Discipline
Life Sciences

Job description

Associate Director, Clinical Science

Cambridge, MA

A growing biotech organization is seeking a resourceful and collaborative Associate Director/Director as the first Clinical Science member of the Medical team, to support programs across a diverse portfolio of programs revolutionizing the field of organ transplantation. This individual will play a key role in operationalizing clinical programs across a growing pipeline. The Clinical Scientist will collaborate cross-functionally with Medical, Clinical Operations, Regulatory, Preclinical, and Translational teams to execute study protocols and ensure the collection of high-quality, interpretable data.

Key Responsibilities

  • Support execution of early-phase clinical trials, ensuring adherence to regulatory and scientific standards.
  • Contribute to protocol development for multiple organ-based programs.
  • Collaborate with Clinical Operations to optimize protocols, study documents, site selection, and enrollment strategies.
  • Ensure protocol adherence and data integrity across clinical programs.
  • Partner with internal stakeholders to support study strategy and execution.
  • Address scientific and procedural questions from clinical sites related to data collection and assessments.
  • Oversee vendors conducting specialized testing or assays to ensure alignment with protocol and data quality standards.
  • Review clinical data for completeness, interpretability, and alignment with study endpoints; identify and resolve data gaps or inconsistencies.
  • Integrate data from external labs, registries, and other sources for comprehensive analysis.
  • Prepare clinical data summaries for internal and external presentations and contribute to regulatory submissions.
  • Support development of responses to regulatory agencies as part of cross-functional teams.

Basic Qualifications

  • Ph.D., PharmD, RN, or Master’s degree with 5+ years of experience in clinical research or drug development in a biotech setting.
  • Experience with transplant medicine, hepatology, nephrology, and/or renal diseases. 
  • Strong understanding of clinical trial design, data collection standards, and GCP guidelines.
  • Demonstrated analytical skills and ability to interpret complex clinical data.
  • Experience working with clinical sites and external vendors.
  • Excellent communication and collaboration skills across multidisciplinary teams.