Director, Clinical Development

Insmed Inc. • Bridgewater, NJ • 2w ago

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Overview The Director, Clinical Development will play a meaningful role in working with the team to implement the global clinical development plans of treatment for the CRS indication. Tasks include preparing clinical documents (e.g. protocol, study report, NDA documents), providing medical oversight for investigational sites, doing research, and participating in and providing medical/scientific leadership to study team(s). In addition, a highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the CRS program. Strong leadership skills are a must for this highly visible opportunity. This position will require working in a fast-paced, high energy, entrepreneurial environment. This role can be remote within the Eastern Time Zone Responsibilities Provide medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study. Provide medical expertise where needed. Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements. Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs. Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews. Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of queries to address information gaps in CIOMS of such deaths. Review of SUSARs and contact with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each individual case. Collaboration in the presentation of safety aspects in the Medical Monitoring Meeting * Colla

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