Senior Director, Clinical Development

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 Senior Director, Clinical Development will play an important role in working with the team to execute the global clinical development plans of Arikayce for the MAC lung disease 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). A highly strategic mindset and strong leadership skills are a must for this highly visible opportunity. This position will require working in a fast-paced, high energy, entrepreneurial and highly collaborative environment. Responsibilities This opportunity will initially focus on safety surveillance, risk management, and medical assessment of individual adverse event reports in the Arikayce PMR program. Additional representative responsibilities will include, but not necessarily be limited to, the following: 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 (which may include assisting colleagues in Pharmacovigilance). 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 drafts, 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 inhaled antibiotics, liver enzymes. Review of mortality cases, evaluation of CIOMS, production of queries to address information gaps in CIOMS. Review of SUSARs and contact with to understand the case assessment. Production of initial narrative to understand each individual case and collaboration with DSPV on comprehensive evaluation and documentation of SUSAR for regulatory and CSR reporting. Collaboration in the presentation of safety aspects in the Medical Monitoring Meeting. Collaborate within Safety Management Team. Provide medical/scientific review of statistical analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, report development and database lock processes. Keep up to date on scientific and medical progress in the area of development and actively develop and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups. Contribute to the strategic development of early and late stage clinical programs. Job Requirements: Requires an MD or DO degree, board certified/eligible and/or specialization in pulmonary is a plus. A minimum of 5 years of clinical development experience in the pharmaceutical/biotech Industry, specifically in mid-to-late stages of development. Clinical development experience working on original NDA/BLA, or sNDA/sBLA critical; Respiratory therapeutic area not required but a plus. Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies. Must have a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies. Must have excellent communication skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Must have strong analytical skills. Must work well both independently and in teams, have excellent time management skills and be able to work well under pressure. Vendor management experience is a plus. Must successfully exhibit Insmed's five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity. Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. LI-MM1 Salary Range $290,000 - $347,600 a year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work, regionally based Competitive compensation package including bonus Stock options and RSU awards Employee Stock Purchase Plan (ESPP) Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS: 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity insurance Employee Assistance Program (EAP) Mental Health on-line digital resource Well-being reimbursement Paid leave benefits for new parents Paid time off to volunteer On-site, no-cost fitness center at our U.S. headquarters Additional Information Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewardsinsmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Applications are accepted for 5 calendar days from the date posted or until the position is filled.