Sr Dir, Clinical Dev

Senior Director, Clinical Development East Coast, NJ (Remote) Biotechnology Company - United States (Remote) Expanding pharma looking to hire a Sr. Director Clinical Development that will provide strategic and operational leadership for late-stage clinical programs within a rapidly growing biotechnology company. Position is critical to advancing therapeutics through Phase III development, registration, and preparation for commercialization. They are targeting someone who can bring deep scientific expertise, proven cross functional leadership, and experience navigating the complexities of late-stage clinical execution in a biotech environment. Description: Lead clinical strategy and execution for late-stage development programs, ensuring scientific rigor and operational excellence. Oversee Clinical Development Plans , endpoint strategy, statistical considerations, and evidence generation pathways. Partner closely with regulatory leaders to prepare for major health authority interactions and global submissions. Drive protocol development, and database build requirements for Phase III programs. Guide cross-functional teams—including Clinical Operations, Biometrics, Regulatory, and Medical Affairs—through complex decision-making. Oversee ongoing medical data review, safety evaluation, and study conduct at global investigative sites. Engage Key Opinion Leaders to inform strategy, enhance trial design, and strengthen scientific credibility. Prepare and deliver scientific presentations for internal governance, external conferences, and investigator meetings. Mentor junior clinical scientists and contribute to organizational capability-building within a scaling biotech environment. Required: PhD in a life science’s, Immunology, Molecular Genetics or related discipline. 8+ years of experience in Clinical Development with extensive Phase III and registrational trial experience. Proven track record advancing biologic and/or small-molecule therapies in a biotech environment. Strong experience interacting with FDA, EMA, PMDA, and other global health authorities. Demonstrated ability to lead cross-functional teams and manage multiple high-priority programs simultaneously. Exceptional communication skills, with experience presenting to scientific conferences and internal governance bodies and can thrive in a fast-paced, late-stage biotech environment with evolving priorities. Excellent base pay plus bonus and stock, full benefits. Please contact Darren Gutowski at [email protected]