About Facet Life Sciences

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. We are a lean, high-impact team built for clients who need senior-level expertise without the overhead of a large CRO. At Facet, you will work directly with Sponsor decision-makers, move quickly, and have meaningful influence on programs that matter.

Our mission is to make life sciences’ dreams a reality. Come join us and help write the next great success story!

The Opportunity

Facet is expanding its Clinical Regulatory Affairs practice and is seeking a senior leader to help anchor and grow the function. This is a player-coach role: you will lead clinical and regulatory strategy for clients, execute high-quality deliverables, and help shape the systems, standards, and capabilities of Facet’s organization .

You will serve as a trusted partner to biotech and pharma leadership teams, guiding programs from early development through key FDA milestones. The ideal candidate is equally comfortable presenting regulatory strategy to a Board of Directors, leading FDA meeting preparation, and rolling up their sleeves to author critical submission documents.

This role is well suited for someone who thrives in ambiguity, can quickly understand novel products and complex data, and can translate scientific and regulatory complexity into clear, actionable recommendations for clients.

The Role

Clinical and Regulatory Strategy

·   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.

Regulatory Operations and FDA Engagement

·   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.

Stakeholder Engagement

·   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.

Practice Leadership and Operations

·   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.

·   Occasional overnight travel expected, approximately 10-40% depending on client needs.

Clinical Operations (secondary)

·   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.

Who We Are Looking For

Education and Experience

·   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.

Skills and Competencies

·   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.

Compensation and Location

This is a remote, US-based role.

Salary and total compensation are competitive with the market for this level of expertise. We are a small company with big company benefits.  Providing great benefits to keep our Facet colleagues healthy and happy is a core value for us.  We provide the following:

·       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

·       Generous sick and vacation time

This is a remote, US-based role.