Director, Corporate Counsel

Overview

This role involves supporting internal stakeholders across the drug development and manufacturing lifecycle, with an emphasis on transactional legal matters. The position advises teams from pre-clinical through commercial readiness and serves as a key advisor to functions including Clinical Science, Clinical Operations, CMC & Technical Operations, Supply Chain, Medical Affairs, and other departments as needed.

The Director, Corporate Counsel reports directly to the Executive Director, Corporate Counsel.

Responsibilities

• Lead the drafting, review, negotiation, and execution of a broad spectrum of agreements, including:
  • Clinical trial agreements
  • Clinical site and investigator agreements
  • CRO and other vendor services agreements
  • Master services agreements, work orders, and change orders
  • CDMO development agreements
  • Supply agreements and manufacturing services agreements
  • Quality agreements
  • Material transfer agreements and technology transfer arrangements
• Review and advise on clinical trial-related documents, including:
  • Informed consent forms
  • Letters of authorization
  • Letters of indemnification
  • Provide strategic legal counsel to clinical trial teams
• Advise stakeholders on contractual risk allocation and related issues, including:
  • Indemnification
  • Limitations of liability
  • Ownership of intellectual property
  • Data rights
  • Confidentiality
  • Regulatory compliance
• Review and advise on external-facing materials and outreach initiatives, including risk mitigation related to potential legal issues
• Help develop Legal Department policies, procedures, templates, and playbooks
• 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
• Perform other duties as assigned

Qualifications

Education

• JD degree or equivalent from an accredited law school required
• BSc in molecular biology, genetics, biochemistry, or another 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)

Experience

• 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 counseling life sciences clinical and manufacturing teams on day-to-day transactions and risk mitigation
• Proven experience reviewing and negotiating a wide range of contracts under tight timelines with autonomous decision-making
• Proficient knowledge of current laws, regulations, and industry standards, including 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
• Experience handling commercial contract disputes and dispute resolution
• Excellent analytical skills, creative and pragmatic problem-solving in a transactional context, and efficient, precise drafting of customized agreements
• Experience working with Finance teams and auditors, managing contract processes and policies, and using contracts lifecycle management tools

Other Qualifications / Skills

• Service-oriented focus with the ability to work in cross-functional teams and drive results
• Highest integrity and excellent judgment; ability to proactively recognize and communicate legal issues to the Executive Director, Corporate Counsel, and other company management
• Leadership qualities, including identifying gaps and a “step-up” mentality to drive solutions
• Ability to manage a full docket in a dynamic, fast-paced environment with aggressive timelines

Compensation & Benefits

• Base salary compensation range: $242,000 - $282,000
• Salary offered to the final candidate depends on factors including geographical location, relevant work experience, skills, and years of experience.

Location

• Travel: 5%

Working Conditions

• Physical requirements: Sedentary work; up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects (sedentary work involves sitting most of the time)
• Working conditions: The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work)

Equal Opportunity

The employer provides equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial, and local laws.