Senior Director, Clinical Development

Insmed Inc. • Bridgewater, NJ • 12h 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 role as a Clinical Indication Lead will be responsible for the clinical input into broader TPIP program strategy related to the pulmonary arterial hypertension indication in mid-to-late-stage development. In addition, this role will be responsible for developing clinical strategic direction of engagements with health authorities related to the registration program and anticipated filings in collaboration with the Clinical Program Lead for TPIP. The individual will articulate the clinical goals (based on the Global TPP), clinical and safety strategy, and the underlying science and clinical need to internal and external audiences with clarity and credibility. Responsibilities Leads clinical development team responsible for mid-to-late-stage development of TPIP in the PAH indication. Leads the matrix Clinical Study Team (CST) to effectively make decisions and handle conflict and change. Responsible for maintaining a high degree of CST effectiveness through collaboration, influence, and, as necessary, coaching of cross-functional team members. Collaborates with the Clinical Program Lead (CPL) to represent to the matrix Global Asset Team to ensure clinical program is represented and integrated into Global plans across functions. Collaborates with the CPL to build strategic and coordinated clinical development plans which are aligned with business objectives (TPP) and are differentiated from competitor products. Responsible for all clinical aspects of the clinical indication strategy. Accountable for the delivery of projects, partnering with other global development and related functions.Requirements/Qualifications: MD/DO equivalent with preference for Cardiology or Pulmonary formal training. Will consider industry experiences in Pulmonary or Cardiology in drug development. 6+ years in biotech or pharma with most in a global clinical development role OR equivalent research experience. Combination of drug/device experience is a plus. sNDA or sBLA experience or original NDA or BLA experience preferred. Experience with J-NDA is a plus. Prefer experience in FDA advisory committee, or CHMP Scientific Advisory Group, or CHMP Oral Explanation. Previous direct people management required. * Experience working in matrix development teams, e.g. Global Study Te

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