Senior Counsel, Clinical/R&D Legal
About The Position
Lakefront Biotherapeutics is a global biotech company with offices in Belgium, Chicago, and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease. Our lead asset is being developed for severe immune‑mediated diseases, while additional preclinical programs expand the long‑term potential of our R&D pipeline. At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities. We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, we operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully. We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients. If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.
Requirements
- 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).
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.
- 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.
Benefits
- Competitive compensation and benefits package
- Dynamic and collaborative work environment designed to support both professional growth and day‑to‑day engagement.
- Performance bonus plan
- Comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
