Senior Counsel Clinical R D Legal positions focus on delivering results in their domain. This page aggregates open Senior Counsel Clinical R D Legal roles and what employers typically expect.
**ABOUT LAKEFRONT BIOTHERAPEUTICS** Lakefront Biotherapeutics is a global biotech 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. Are you ready to transform lives and be part of a journey like no other? 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. **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. **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 dev…