Note: The job is a remote job and is open to candidates in USA. Facet Life Sciences is a specialized strategic regulatory affairs and product development consulting organization that helps emerging biotech and pharma companies advance drugs, biologics, devices, and combination products through regulated development in the United States. They are seeking a Director of Clinical-Regulatory Strategy to lead clinical and regulatory strategy for clients, execute high-quality deliverables, and shape the systems and standards of Facet’s organization.
Responsibilities
- Provide scientific leadership and clinical-regulatory strategy across assigned client programs and therapeutic areas
- Design and execute US regulatory and clinical development strategies for investigational and approved products
- Interpret and critically evaluate clinical data, including Clinical Study Reports, to inform regulatory strategy, submission narratives, and development pathways
- Advise on and support IND, NDA, BLA, IDE, 510(k), De Novo, and other regulatory submissions, ensuring consistent clinical messaging across components
- Develop strategy for FDA meetings, expedited programs, and designations, including Pre-IND, Fast Track, orphan drug, and breakthrough therapy pathways
- Evaluate scientific evidence from preclinical development through proof of concept and late-stage milestones
- Synthesize secondary research across therapeutic areas and translate findings into executive summaries, Board materials, investor presentations, and client-ready recommendations
- Serve as US Agent and/or primary FDA liaison on behalf of Facet clients across drug, biologic, device, and combination product programs
- Lead FDA meeting activities end-to-end, including meeting strategy, briefing materials, rehearsal facilitation, meeting participation, minutes, and follow-up actions
- Use clinical data outputs to inform integrated summaries of safety and efficacy, benefit-risk narratives, and labeling strategy
- Review clinical and regulatory submission documents as needed, including investigator brochures, informed consent forms, ISE/ISS, and product labeling
- Monitor relevant regulatory developments and communicate implications to client and internal teams
- Build trusted relationships with clients and scientific stakeholders
- Develop materials that communicate the strategic, scientific, and clinical value of programs to technical and executive audiences
- Serve as a cross-functional clinical and regulatory representative on client project teams
- Maintain project timelines, manage priorities, and operate within contracted budgets
- Work in accordance with ICH guidelines and applicable US federal regulations
- Contribute to practice growth by identifying client needs, shaping scopes of work, mentoring colleagues, and improving repeatable delivery models
- Help clients oversee clinical trials, CROs, investigational sites, and clinical vendors
- Guide cross-functional teams through strategic protocol development, aligning clinical operations, biostatistics, regulatory affairs, medical writing, and client leadership around actionable study designs
- Identify operational, scientific, and regulatory risks early and recommend practical mitigation strategies
Skills
- MD, PhD, PharmD, or equivalent advanced degree preferred; MS, MBA, or other relevant degree may be considered with an exceptional development background
- 8-20 years of experience in pharmaceutical, biotech, medical device, or life sciences consulting environments
- Consulting experience required, especially in roles with senior client interaction and hands-on deliverable ownership
- Demonstrated experience leading regulatory strategy and submissions across multiple product types, including drugs, biologics, devices, or combination products
- Track record of successful FDA interactions and clinical development leadership from early development through major regulatory milestones
- Experience developing innovative clinical and regulatory strategies for programs with scientific, clinical, or regulatory ambiguity
- Regulatory and clinical expertise: deep working knowledge of clinical trial design, clinical development, regulatory strategy, and FDA expectations across relevant product categories
- Scientific and analytical judgment: ability to synthesize large volumes of scientific and clinical information into clear, actionable insights; comfortable making recommendations with incomplete data
- Executive communication: outstanding written and oral communication skills, with the ability to produce executive-quality PowerPoint presentations and submission-quality documents
- Strategic thinking: able to develop analytical frameworks, anticipate clinical and regulatory implications, and align teams around a practical path forward
- Execution discipline: highly organized, self-directed, and able to manage competing priorities in a fast-paced, multi-client consulting environment
- Collaborative presence: team-oriented, intellectually curious, and a strong listener who earns trust quickly with senior clients and scientific stakeholders
Benefits
- Health insurance plan
- Supplemental insurance
- Dental insurance
- Life insurance
- Short- and long-term disability insurance
- 401K program
- Several bonus programs
- Company-supported, required annual training
- Flexible work environment
- Unlimited sick and vacation
Company Overview