Director, Clinical R&D

NEXT Life Sciences is seeking an experienced, hands-on Director, Clinical R&D to assist product development and clinical execution across the company’s pipeline. The role reports to the Chief Technology Officer.

This is a working Director role in a small company. The Director will implement clinical studies, manage CROs and study sites, build and implement study budgets, and help move development-stage products through the 505(b)(2) pathway. There are currently no other employees under this seat. The right person is as comfortable writing a protocol synopsis or reviewing a monitoring report as presenting a development plan to the executive team.

The successful candidate brings direct experience developing new formulations, combinations, indications, or dosing approaches for already approved drugs, along with hands-on responsibility for clinical trial operations. Oral solid dose and topical experience is strongly preferred. CMC and drug raw material sourcing experience is a plus. A background in urology or men’s health is also a plus.

This person must be able to operate independently, make sound scientific and operational decisions with limited direction, and keep multiple programs moving in a fast-paced, investor-backed environment.

• Lead clinical development execution for assigned pipeline programs, from development planning through study close-out.
• Contribute to the design of clinical studies, including protocols, endpoints, study populations, and statistical approach, working with internal leadership and external advisors.
• Implement 505(b)(2) development plans, including reference listed drug procurement, bridging strategy, and the nonclinical and clinical data needed to support approval.
• Select, contract, and manage sites, CROs, central labs, and other clinical vendors, and hold them to scope, timeline, quality, and budget.
• Evaluate and qualify study sites, oversee site activation, and manage site monitoring and performance.
• Prepare clinical study budgets, track spend against plan, and raise variances early.
• Coordinate with CMC and manufacturing partners on clinical supply, including active and placebo product for blinded studies.
• Author and review clinical and regulatory documents, including protocols, investigator brochures, IND sections, clinical study reports, and FDA meeting packages.
• Ensure studies are conducted in compliance with GCP, ICH guidelines, and applicable FDA regulations.
• Maintain study timelines, risk logs, and decision records, and report program status to the CTO and executive team.
• Prepare clinical and development materials for financing, partnering, Board meetings, and due diligence.
• Contribute to pipeline planning and portfolio decisions as new products move toward the clinic.

• At least 8 years of drug development experience, including at least 3 years in clinical R&D at a drug development company.
• Direct experience developing products through the 505(b)(2) pathway.
• Hands-on responsibility for clinical trial operations, including CRO management, site evaluation, and site monitoring.
• Experience preparing and managing clinical study budgets.
• Working knowledge of GCP, ICH guidelines, and FDA regulations governing clinical development.
• BS or BA in biology, chemistry, pharmacology, or a related scientific field.
• Strong scientific writing, including protocols, study reports, and regulatory documents.
• Proven ability to work independently in a small company and manage multiple programs with limited direction.

• PhD, PharmD, MD, or other advanced degree in a related scientific field.
• Oral solid dose development experience. Topical experience is also valued.
• Urology or men’s health experience.
• Start-up or early-stage company experience.
• Direct…