Associate Director, Clinical Counsel

Role Summary

The Associate Director, Clinical Counsel provides legal support to the clinical contracting team of the Legal Department in support of Insmed’s clinical trial pipeline, and provides administrative support to the team as needed.

Responsibilities

• Draft, review, and negotiate clinical trial agreements, local representation agreements, informed consent documents, and other documents required for legal, ethical, and compliant conduct of clinical trials.
• Provide day-to-day legal advice in the review and negotiation of vendor contracts, including CRO agreements, master services agreements, and confidentiality agreements related to clinical development and operations to support timely and compliant initiation of all trial phases.
• Build constructive working relationships with clients and act as an active member of Legal and client teams.
• Coordinate and oversee legal matters handled by outside counsel.
• Represent Legal in clinical study team meetings.
• Partner with internal cross-functional stakeholders to apply legal and regulatory frameworks to business activities, understanding goals and developing solutions to achieve outcomes.
• Assist in data management of data points from the review and filing of emails in central email inbox.
• Organize and file clinical contracts and amendments in SharePoint.
• Prepare and manage final execution of clinical contracts and amendments.
• Collaborate in managing and tracking the execution process of a high volume of clinical contracts from initial preparation through to execution (including DocuSign and hard copy as applicable).

Qualifications

• JD degree and bar admittance in New Jersey (or eligibility for limited in-house license) with a minimum of 2 years of related legal experience representing life sciences companies in a law firm, biopharmaceutical company, or contract research organization.
• 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.
• Ability to stay abreast of new laws, regulations, and industry trends that may affect Insmed and clinical objectives.
• Analyze and apply government regulations, guidelines, and requirements; interpret policies and develop procedures with good judgment.
• Demonstrated adaptability and efficiency in a fast-paced work environment; willingness to collaborate and take direction.
• Superior oral and written communication and interpersonal skills.

Education

• Juris Doctor (JD) degree; bar admission in New Jersey or eligibility for limited in-house license.

Skills

• Strong negotiation and contract management skills in a clinical trial context.
• Excellent written and verbal communication and collaboration abilities.
• Regulatory knowledge across clinical, FDA, and drug laws relevant to biopharmaceuticals.
• Data management and organizational skills for handling high volumes of contracts and amendments.

Additional Requirements

• Fully remote role; can be performed effectively from anywhere with connectivity to the team. Occasional travel for team meetings or events.