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Insmed Incorporated
NJ Corporate Headquarters, New Jersey, United States
(on-site)
Posted
1 day ago
Insmed Incorporated
NJ Corporate Headquarters, New Jersey, United States
(on-site)
Job Type
Full-Time
Job Function
Legal
Associate Director, Clinical Counsel
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Associate Director, Clinical Counsel
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
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:
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 Legal and client teams.
- Coordinate and providing oversight of legal matters handled by outside counsel.
- Provide Legal representative in clinical study team meetings.
- Assist in partnering 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 data 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 management and tracking of execution process of high volume of clinical contracts from initial preparation through to execution (including DocuSign and hard copy, where applicable).
Who You Are:
You have a JD degree and bar admittance in New Jersey (or eligibility for limited in-house license) and a minimum 2 years related legal experience representing life sciences companies in a law firm, a biopharmaceutical company, and/or a contract research organization.
Additionally, you have:
- 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.
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 will be expected.
#LI-SK1
#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
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 ID: 81786593
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. We are dedicated to making a meaningful impact in patients’ lives as well as the communities where we live and work. Our team is guided by our core values of collaboration, accountability, passion, respect, and integrity.
Insmed is headquartered in Bridgewater, NJ, and has offices and research locations throughout the United States, Europe, and Japan....
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