Senior Counsel, Clinical/R&D Legal

THE OPPORTUNITY

We are seeking a Senior Counsel, Clinical/R&D Legal to join our legal team. This is an opportunity to take ownership of core legal support for our evolving clinical operations, manufacturing, research and development teams, and regulatory affairs team, while developing into a broader strategic advisor across the business. The position offers significant autonomy and direct partnership with senior stakeholders. Over time, the successful candidate will have meaningful opportunities to expand into additional areas, including strategic licensing and business development transactions, healthcare compliance, privacy, pre-commercial planning, legal operations and AI-enabled legal tools, and other corporate and operational matters.

This is a hands-on role for a lawyer who wants direct access to senior stakeholders, meaningful autonomy, and the ability to grow with the company as Lakefront continues to build its pipeline, capabilities, and operating model. You will have opportunities to learn from experienced colleagues, contribute to strategic projects, and progressively broaden your responsibilities as the company grows. This is a hybrid role in our South San Francisco office and remote candidates will not be considered.

WHAT YOU'LL DO

Primary Responsibilities:

• Lead the drafting, negotiation, and management of a broad range of clinical development, research, manufacturing, and vendor agreements, including clinical trial agreements (CTAs), investigator and site agreements, MSAs, SOWs, CRO agreements, laboratory services agreements, CMO agreements, and other strategic vendor arrangements.
• Serve as a trusted legal partner to clinical, research, manufacturing, regulatory, pharmacovigilance, quality, data management, and project management teams by providing practical, risk-based legal advice on day-to-day operational matters.
• Support regulatory affairs team with legal issues arising from their interaction and coordination with regulatory authorities, including the FDA, EMA, and other global health authorities.
• Advise on legal and compliance issues related to clinical development, medical affairs, regulatory affairs, healthcare compliance, interactions with healthcare professionals and patient advocacy organizations, privacy, and pre-commercial activities.
• Collaborate with Privacy, Information Security, Clinical Operations, and HR to address cross functional compliance issues, such those under HIPAA and GDPR
• Monitor relevant legal and regulatory developments affecting the biotechnology and pharmaceutical industries and provide timely guidance to stakeholders on emerging risks and opportunities.

Growth and Expansion Opportunities

In addition to the role's core Clinical/R&D responsibilities, this position is designed to provide exposure to broader legal and business issues over time, including:

• Strategic licensing, business development, supply, services, consulting, confidentiality, and other commercial agreements.
• Contract lifecycle management initiatives and AI-enabled legal technologies, including stakeholder training, governance, policy development, implementation, and ongoing optimization.
• Provide broad-based cross-functional legal support across the organization consistent with the needs of a lean, high-performing legal team, including employment matters (in coordination with HR and outside counsel), litigation management, intellectual property coordination, public affairs and communications review, vendor and technology contracting, policy development, and training.
• Opportunities to help build scalable legal processes, templates, playbooks, and practical ways of working.

WHAT YOU BRING

• JD and active membership in at least one U.S. state bar
• 6-12 years' experience in biotech/pharma
• In-house experience preferred
• Strong clinical contracting experience preferred
• Practical, business-oriented mindset with an ability to work effectively with cross-functional stakeholders and build trust with business partners
• A practical, business-oriented approach and the ability to provide clear, risk-based legal advice
• Strong ownership mindset: proactive, organized, responsive, and able to manage multiple priorities under time pressure.
• Experience managing outside counsel, including scoping, budgets, timelines, and deliverables.
• Experience scaling legal processes (AI legal operations, templates, playbooks, contracting management process).

WHAT WE OFFER

We provide a competitive compensation and benefits package, along with a dynamic and collaborative work environment designed to support both professional growth and day‑to‑day engagement. Base compensation for this position ranges from $275,000 to $300,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.