Director, Corporate Counsel

Remotefull time

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Remote

senior

H1B: no

4dmoleculartherapeutics Director, Corporate Counsel at 4dmoleculartherapeutics providing transactional legal support across drug development and manufacturing lifecycle. Leads drafting, negotiation, and management of contracts with clinical trial sites, CROs, vendors, and partners.

Responsibilities

MAJOR DUTIES & RESPONSIBILITIES:
Lead the drafting, review, negotiation, and execution of a broad spectrum of agreements including, without limitation, clinical trial agreements, clinical site and investigator agreements, CRO and other vendor services agreements, master services agreements, work orders, change orders, CDMO development agreements, supply agreements, manufacturing services agreements, quality agreements, material transfer agreements, and technology transfer arrangements.
Review and advise on clinical trial related documents, such as informed consent forms, letters of authorization, and letters of indemnification, and provide other strategic and legal counsel to clinical trial teams.
Advise stakeholders on contractual risk allocation, indemnification, limitations of liability, ownership of intellectual property, data rights, confidentiality, and regulatory compliance, providing practical, risk-based legal counsel to support the timely progression of clinical programs and business initiatives.
Review, approve, and advise on external facing materials & outreach initiatives, providing counsel on potential legal issues and appropriate risk mitigation strategies related thereto.
Assist with development of Legal Department policies, procedures, templates, and playbooks relating to Legal Department activities.
Participate in and support continuous improvement of the contracts lifecycle management system.
Manage the use of outside counsel taking into account cost, speed of review, and technical expertise.
Other duties as assigned.

Qualification

BSc in molecular biologyAdmission to8+ years practice as an attorneyProficient knowledge of current laws

Required

JD degree or equivalent from an accredited law school required.
BSc in molecular biology, genetics, biochemistry, or other biological field related to the biopharma industry is beneficial but not required.
Admission to, and in good standing with, at least one U.S. state bar (CA preferred but not required).
8+ years practice as an attorney
5+ years of in-house experience in the life sciences industry
In-house experience at a publicly traded biotechnology, pharmaceutical, or biopharmaceutical company strongly preferred.
Large law firm experience supporting life sciences companies strongly preferred.
Experience in counseling life sciences clinical and manufacturing teams with respect to day-to-day transactions and risk mitigation strategies.
Proven experience reviewing and negotiating a wide-range of contracts described herein under tight timelines and with autonomous decision making.
Proficient knowledge of current laws, regulations and industry standards, such as FDA regulations, ICH Guidelines, GxPs, FDCA, FCPA, FCA, AKS, HIPAA, and data privacy laws.
Prior experience supporting global clinical trials, including registrational trials, intellectual property and technology related transactions is beneficial to the role.
Experience handling commercial contract disputes and dispute resolution.