Senior Vice President, Clinical Affairs

NEXT Life Sciences is seeking a Senior Vice President, Clinical Affairs to own clinical strategy and execution across the company’s full portfolio of medical device and pharmaceutical products. The role reports to the Chief Executive Officer, Darlene R. Walley, PhD.

This is the company’s senior clinical leader. The SVP sets the clinical development plan for every program, leads the clinical operations team, and is accountable for each study from design through regulatory submission. The portfolio runs on two regulatory tracks. Plan A™ is a medical device. Pause Pill™ and several pipeline programs are drugs. The SVP must be fluent in both and know where they differ in study design, evidence standards, and FDA expectations.

The successful candidate has taken products through pivotal trials and into FDA submissions, built and led clinical teams, and managed CROs and budgets at the program level. Experience on both the device and drug sides is strongly preferred. A background in urology, reproductive health, or men’s health is strongly preferred.

NEXT Life Sciences is a new, investor-backed company, and this role stays close to the work. The SVP will write and review key documents, lead FDA meetings, and present the clinical story to the Board, investors, and partners.

Key Responsibilities

• Set clinical strategy and integrated development plans for all programs, device and drug, from first-in-human studies through approval and post-market commitments.
• Lead the clinical operations team, including hiring, development, and performance, and build out the clinical organization as the pipeline grows.
• Own the design of pivotal and supporting studies, including endpoints, study populations, statistical approach, and the evidence package each product needs for approval.
• Direct device clinical programs under IDE, including the clinical sections of PMA, De Novo, or 510(k) submissions.
• Direct drug clinical programs under IND, including 505(b)(2) strategy and the clinical sections of NDA submissions.
• Lead clinical interactions with FDA, across both CDRH and CDER, in partnership with regulatory. This includes pre-submission, pre-IND, End-of-Phase 2, and pre-NDA meetings.
• Set CRO and vendor strategy, approve major clinical contracts, and hold partners to scope, timeline, quality, and budget.
• Own the clinical budget across the portfolio, forecast spend by program, and raise variances early.
• Oversee medical monitoring and safety reporting for device and drug studies, including adverse event and serious adverse event processes.
• Ensure all studies comply with GCP, ICH guidelines, ISO 14155, and applicable FDA regulations, and keep the company inspection-ready.
• Review and approve protocols, investigator brochures, clinical study reports, and the clinical sections of regulatory submissions.
• Build relationships with principal investigators, key opinion leaders, and clinical advisors in urology and reproductive health, and set publication strategy for clinical results.
• Present clinical strategy, results, and risk to the CEO, Board, investors, and partners, and lead the clinical workstream in financing, partnering, and due diligence.
• Advise on pipeline and portfolio decisions, including which programs move into the clinic and when.

Qualifications

• At least 15 years of clinical development experience at medical device, pharmaceutical, or biotech companies, including at least 8 years in clinical leadership positions.
• Led at least one product through pivotal trials and an FDA marketing submission (PMA, De Novo, 510(k), or NDA).
• Direct experience leading clinical meetings with FDA.
• Clinical development experience on both device and drug programs, or deep experience in one with working fluency in the other. Experience with the 505(b)(2) regulatory pathway is ideal.
• Built and managed clinical budgets at the program or portfolio level, and managed CROs and vendors to contract.
• Expert knowledge of GCP, ICH guidelines, ISO 14155, and FDA regulations governing device and drug studies.
• Bachelor’s degree in life sciences, nursing, or a related field. PhD, MD, or equivalent is ideal.
• Strong scientific and regulatory writing skills.
• Proven ability to lead in a fast-paced company, set pr