Director, Clinical R&D

NEXT Life Sciences, Inc.; United States; Remote; USD 180,000 - 200,000; Full time

Benefits offered by this job

Stock options

Health, dental, and vision insurance

Unlimited PTO

Job summary

NEXT Life Sciences is seeking an experienced Director, Clinical R&D to drive clinical development across the company’s pipeline. The role reports to the CTO and requires hands-on leadership in study design, site management, and CRO coordination in a fast-paced, investor-backed environment.

The ideal candidate has 8+ years in drug development with 3+ years in clinical R&D, plus experience with 505(b)(2) development and regulatory documentation. Remote work is available in the United States.

Qualifications

• 8+ years in drug development, incl. 3+ years in clinical R&D.
• Experience advancing products via 505(b)(2) pathway.
• Hands-on clinical operations including CRO management.
• Experience budgeting clinical studies.
• Knowledge of GCP, ICH, and FDA clinical development rules.
• BS/BA in biology, chemistry, pharmacology, or related field.
• Strong scientific writing for protocols, reports, and regs.
• Ability to operate independently in a small company.

Responsibilities

• Lead clinical development execution from planning to close-out.
• Design protocols, endpoints, populations, and stats with leaders/advisors.
• Implement 505(b)(2) plans including reference drug and bridging strategy.
• Select, contract, manage sites, CROs, labs, and vendors to meet scope and budget.
• Oversee site activation, monitoring, and performance.
• Prepare budgets and track spend, flag variances early.
• Coordinate with CMC/manufacturing on clinical supply.
• Author/review protocols, investigator brochures, IND sections, study reports, FDA packages.
• Ensure studies comply with GCP, ICH, FDA regs.
• Maintain timelines, risk logs, and report status to CTO/exec.
• Prepare materials for financing, partnering, Board meetings, due diligence.
• Contribute to pipeline planning as products move to clinic.

Skills

8+ years in drug development

Clinical R&D

505(b)(2) pathway

CRO management

Clinical study budgets

GCP/ICH/FDA compliance

Education

BS/BA in biology, chemistry, pharmacology

PhD/MD preferred

Job description

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.

Key Responsibilities

• 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.

Qualifications

• 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.

Preferred

• 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 interaction with FDA, including pre-IND, End-of-Phase 2, or pre-NDA meetings.

The Details

• Reports to: Chief Technology Officer
• Location: Remote, United States.
• Work Arrangement: This is a remote position. The role requires the flexibility to support study timelines, CRO and site schedules, and time-sensitive program needs.
• Salary: $180,000 to $200,000, depending on experience, scientific background, and qualifications.
• Equity: Company stock options are included as part of the overall compensation package.
• Benefits: Health, dental, and vision insurance, with the majority of costs covered by NEXT Life Sciences.
• Paid Time Off: The company maintains an unlimited PTO policy designed to provide flexibility while ensuring business needs, team commitments, and individual responsibilities are consistently met.
• Travel: Periodic travel to study sites, CROs, and manufacturing partners, plus occasional Board, investor, and company meetings.

About NEXT Life Sciences

NEXT Life Sciences is a reproductive health platform company developing high-impact medical devices and pharmaceutical products that address major unmet needs in men’s and women’s sexual and reproductive health.

The company is a leader in non-hormonal male contraception through Plan A™, a long-acting, reversible contraceptive, and Pause Pill™, an on-demand contraceptive pill. Both products have demonstrated safety and efficacy in human clinical trials.

NEXT Life Sciences is also advancing a broader pipeline focused on premature ejaculation, erectile dysfunction, female fertility, and at-home sexually transmitted infection testing. The company is led by an experienced executive and advisory team with a strong track record of building and scaling successful healthcare businesses.

NEXT Life Sciences, Inc. is an equal opportunity employer. We are committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law.