Consulting Opportunity - Contracts Counsel

Merida BiosciencesCambridge, MA, US

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Job Description

Description :

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.

We are seeking a strategic contracts or corporate attorney experienced in the clinical contracting space to drive our clinical contracting efforts. This role will be responsible for spearheading negotiation of clinical site agreements, MSAs with clinical CROs and other clinical stage service providers, and other contracts in support of clinical studies, both directly and with the support of external counsel. This is a key position for advancing our clinical studies, and in-house contracting experience collaborating cross-functionally to drive contracts to execution on timelines that support business goals is imperative.

Responsibilities :

Act as the primary legal contact for the Clinical, Regulatory, Quality, and Translational teams regarding clinical trial-associated contracts.
Collaborate cross-functionally to ensure alignment on contracting strategy, risk tolerance, and business priorities.
Draft and negotiate a wide variety of clinical contracts including CTAs, CDAs, Consulting and Advisory Agreements, CRO MSAs and Work Orders, and DPAs, both directly and supported by external counsel.
Manage external counsel for any outsourced contracts.
Legal review of other clinical documents, as needed, including ICFs.
Work collaboratively with clinical CROs and Clinical Operations to align on site contracting strategy.

Requirements :

JD and 5+ years in house contracts or general corporate experience in a biotech or pharma setting.

At least 3+ years clinical contracting experience, either directly negotiating clinical contracts or managing clinical contracting as part of a broader role and serving as an escalation point.

Strong understanding of the key provisions of clinical contracts.

Ability to produce high quality redlines of clinical contracts with minimal oversight on short turnaround times.

Experience managing external counsel.

Experience collaborating cross-functionally with key functions and external collaborators, including Clinical Operations, Regulatory, Finance, and clinical CROs.

Collaborative, business-minded approach with strong communication and interpersonal skills.

Experience with phase I trials at an early-stage biotech is strongly preferred.

Some knowledge of regulatory law is a plus.

Experience with discovery-phase research and CMC contracts is a plus.

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies : Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

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Counsel • Cambridge, MA, US