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 four 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:
The Associate Director, Clinical Research Scientist will support and work predominately with the Medical Monitor for assigned protocols and/or projects, partnering with vendors and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as well as overall program support ensuring the adherence to all standard operating procedures (SOPs).

What You'll Do:

Participate in cross functional teams to develop and implement Clinical Study protocols within clinical program(s). Responsibilities include but are not limited to:

• Collaborate with internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents.
• Contribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through final reporting of result.
• Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study integrity/conduct, and protocol oversight.
• Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it's 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, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocol.
• 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 development of eCRFs, edit checks, report development, and database lock processes.
• Participate in activities related to data review, database lock, and query resolution for the protocol.
• Contribute to the development and execution of Medical Monitoring plan; support medical monitoring and safety oversight activities.
• Work with medical monitors and drug safety to provide support and scientific review of adverse events and related safety data.
• Provide scientific review of statistical analysis plans, applicable study committees charters, and data outputs.

Support corporate objectives:

• Develop, review, and revise departmental and corporate SOPs and processes.
• Provide clinical development and technical expertise in support of due diligence activities.
• Support regulatory activities at the protocol level to develop, prepare, and respond to regulatory authorities.

Who You Are:

• Master's degree required; PharmD or PhD strongly preferred.
• Minimum of 5 years clinical drug development experience.
• Strong medical writing and presentation skills.
• Understanding of biostatistics and data management.
• Strong data review and analytical skills.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Excellent written and oral communication skills.
• Ability to succeed in fast-paced work environment.
• Demonstrated team-building skills and the ability to work successfully in a matrix team environment.
• Analytical, negotiation, meeting management, and cross-functional team leadership skills required.
• Conflict management, time management, and organizational skills required.
• Must successfully exhibit Insmed's five (5) core values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Individuals must be able to work independently.

#LI-MM1
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Pay Range:
$147,000.00-206,333.00 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.

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.