Job Description
At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
For patients, for each other, and for the future of science, we're in. Are you?
About the Role: We're looking for a Director, Clinical Scientist for the Gene Therapy Clinical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Clinical Development, you will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and cross functional teams. You will provide clinical and scientific support to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring adherence to all standard operating procedures (SOPs).
What You'll Do: Participate in cross functional teams to develop and implement clinical studies within clinical program(s). Responsibilities include but are not limited to: - Collaborate with internal teams, contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and plans
- Contribute to scientific and operational aspects and stages of the protocol development and study execution, from study design planning through final reporting of results
- Provide scientific input and review of clinical study data, support in assessing medical monitoring reports, study integrity/conduct, and study oversight
- Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program
- Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e., IND submissions, IND Annual Updates, DSUR, and Investigator Brochures)
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Provide scientific support to the study teams, including: - Collaborate with team members in the review and development of Data Management activities including eCRFs, edit checks, report development, and database lock processes
- Participate in activities related to data review, database lock, medical monitoring, and query resolution for the protocol and work with other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety data and study plans
Support corporate objectives: - Development, review, and revision of departmental and corporate SOPs and processes
- Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
Who You Are: - Requires an advanced degree (Pharm. D., Ph.D., M.D./ M.D. equivalent preferred) with a minimum 5 years of drug development experience
- Experience with EDC systems (i.e., RAVE) and data analysis tools (i.e., J-Review) required
- Strong medical writing and presentation skills
- Basic understanding of biostatistics and data management
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents
- Excellent written and oral communication skills as well as time management and organizational skills required
- Ability to succeed in fast-paced work environment and work successfully in a matrix team environment
Where You'll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.
Some travel expected
Pay Range: $179,000.00-250,800.00 Annual
Life at Insmed At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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.
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 TotalRewards@insmed.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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Job Tags
Contract work, Local area, Flexible hours,