Associate Director, Clinical Counsel
The Associate Director, Clinical Counsel will provide legal support to the clinical contracting team of the Legal Department in support of Insmed's clinical trial pipeline. The role will also provide administrative support to the team as needed. What You'll Do: In this role you will conduct the drafting, review, negotiation, of clinical trial agreements, local representation agreements, informed consent documents, and other documents required for legal, ethical and compliant conduct of clinical trials by a biopharmaceutical industry sponsor. You'll also:
- Provide day-to-day legal advice in the review and negotiation of vendor contracts , including clinical research organization agreements, master services agreements, and confidential disclosure agreements related to clinical development and clinical operations activities to support timely and compliant initiation of all phases of clinical trial activities.
- Build constructive working relationships with client base and operates as an active member of L egal and client teams.
- Coordinate and provid ing oversight of legal matters handled by outside counsel.
- Provide L egal representative in clinical study team meetings.
- Assist in p artn ering with internal cross-functional stakeholders to proactively apply legal and regulatory framework to business activity by understanding business goals and developing alternative solutions to assist in the achievement of successful outcomes.
- Assist in d ata management of data points from the review and filing of emails in central email inbox.
- Organization and filing of clinical contracts and relevant amendments in SharePoint.
- Preparation and management of final execution of clinical contracts and relevant amendments.
- Collaborate in the m anage ment and track ing of execution process of high volume of clinical contracts from initial preparation through to execution (including DocuSign and hard copy, where applicable).
- Knowledge in negotiation of clinical trial agreements, regulatory matters, risk management and contract management.
- Experience in contract, clinical, FDA, and drug laws and regulations specific to the biopharmaceutical industry.
- Ability to identify, strategize and respond to a broad range of issues related to clinical development, clinical operations and risk management.
- Extensive ability to stay abreast of new laws, regulations and industry trends that may affect Insmed and clinical objectives.
- Analyze, interpret, and apply government regulations, guidelines, and requirements.
- Skilled with the ability to exercise good judgment regarding the interpretation of policies, development of procedures, and selection of appropriate courses of action.
- Demonstrated adaptability and efficiency in a fast-paced work environment.
- Willingness to lean in, collaborate and take direction.
- Superior oral and written communication and interpersonal skills.
- Extensive ability to stay abreast of new laws, regulations and industry trends that may affect Insmed and clinical objectives.
#LI-SK - Remote Pay Range:
$187,000.00-243,500.00 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
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