Serve as Clinical Lead for one or more clinical programs from early- through late-stage development, contributing to strategic planning, protocol design, and execution.
Analyze and interpret clinical trial data, ensuring appropriate actions are taken to advance development programs and inform corporate decision-making.
Lead or support the development of key regulatory documents (e.g., INDs, NDAs, CTAs), study reports, and publications; represent the clinical program in health authority interactions.
Provides oversight and medical accountability for multiple trials across early development clinical lifecycle.
Assesses safety-related adverse events in partnership with Global Safety and oversees contributions to safety narratives.
Strong presentation skills for internal and external (Investigator meetings, DMCs, Steering Committee) communications.
Accountable as a key medical and scientific leader.
Represent the medical and scientific integrity of the company, leading science-driven product development and informing clinically related corporate decisions.
Ensure clinical programs meet required quality and safety standards.
Medical review of clinical documents submitted to regulatory agencies.
Participate in meetings with regulatory agencies as clinical program leader.
Lead publication strategy in close collaboration with relevant internal functions.
Lead interactions and build relationships with medical and scientific advisors, building and maintaining relationships consistent with development and commercial objectives.
Requirements
M.D. (U.S. board-certified) with subspecialty training or experience in Nephrology or Rheumatology/Immunology strongly preferred.
4+ years of clinical development experience in the pharmaceutical, biotech, or academic research setting.
In-depth knowledge of clinical trial design, data analysis, and interpretation in late-stage development.
Strong written and verbal communication skills, with the ability to distill complex clinical data for a range of stakeholders.
Proven ability to work collaboratively in a matrixed, cross-functional team environment.
High integrity, sound judgment, and a passion for advancing transformative therapies.
Benefits
Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial designdata analysisprotocol designregulatory documentssafety narrativesmedical reviewpublication strategyclinical development