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Vera Therapeutics, Inc. · 4 months ago

Senior Director, Clinical Development

United States

Full-time

Remote

Senior Level, Lead/Staff

$330K/yr - $360K/yr

4+ years exp

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Senior Director, Clinical Development will lead ongoing clinical research programs, ensuring the strategic planning, protocol design, and execution of clinical trials while maintaining the medical and scientific integrity of the company.

BiotechnologyHealth Care

Responsibilities

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

Qualification

D. (U.S. board-certified)Nephrology experienceRheumatology/Immunology experienceClinical development experienceClinical trial designData analysisRegulatory document developmentHigh integrityCommunication skillsCollaborative teamwork