Vice President, Clinical Development – Gene Therapy
at Insmed Incorporated
Bridgewater, NJ 08807, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 29 Apr, 2025 | USD 451000 Annual | 29 Jan, 2025 | 12 year(s) or above | Medical Monitoring,Program Management,Platforms,Clinical Development,Statistics,Conference Presentations,Regulatory Requirements,Oversight,Multiple Therapeutic Areas,Thinking Skills,Biostatistics,Regulatory Affairs,Pharmacovigilance,Key Opinion Leaders | No | No |
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Description:
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.
Responsibilities:
- Provide medical/scientific expertise by working closely with Clinical Scientists and Clinical Operations teams throughout the lifecycle of gene therapy clinical studies, from pre-study planning to post-study analysis. Proactively identify and resolve study design issues that may arise during gene therapy trials.
- Co-lead a global study team, alongside Program Management, to advance gene therapy assets, particularly through Phase II and beyond. Collaborate effectively with cross-functional teams such as Data Management, Biostatistics, and Regulatory Affairs, to ensure seamless execution of the gene therapy development plan.
- Offer medical expertise across functions, including collaborating with Drug Safety and Pharmacovigilance to monitor safety signals and manage gene therapy-related adverse events.
- Support the preparation and presentation of scientific materials, such as abstracts, manuscripts, and conference presentations, as well as Advisory Board materials relevant to gene therapy programs.
- Present protocols and other materials at Investigator Meetings, training sessions, and other internal or external forums as needed, particularly related to gene therapy studies.
- Provide medical guidance during data reviews, interim analyses, and blinded data assessments for gene therapy trials.
- Review and provide feedback on statistical analyses and collaborate with Data Management teams on the development of eCRFs, edit checks, coding, and other data processes necessary for gene therapy studies.
- Stay current on scientific and medical advancements in gene therapy and maintain relationships with external experts. Represent Insmed in external groups and professional organizations focused on gene therapy.
- Contribute to the strategic development of both early and late-stage gene therapy clinical programs, ensuring alignment with corporate objectives and regulatory requirements.
- Participate in due diligence activities as needed, contributing medical and scientific expertise during the evaluation of investigational agents and/or platforms
REQUIREMENT SUMMARY
Min:12.0Max:17.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
MD
Proficient
1
Bridgewater, NJ 08807, USA