DIRECT APPLY ONLY, NO RECRUITERS

Position Overview:

The Chief Medical Officer (CMO) will be responsible for leading the overall clinical development and regulatory strategy for our male contraceptive lead product Plan A, and the male contraceptive R&D pipeline. This role will work closely with the CEO, and other executive leadership, to ensure alignment of clinical objectives with the company’s strategic goals. The CMO will oversee all aspects of clinical operations, including clinical trial design, implementation, and regulatory compliance, while ensuring the highest standards of patient care and safety.

Our ideal candidate would join us full-time, but we are open to flexible arrangements, including part-time or consulting work, based on experience and fit.

Key Responsibilities:

Clinical Strategy & Leadership:

• Lead the development and execution of clinical strategies for the company’s programs worldwide.
• Collaborate with R&D, regulatory, and commercial teams to align clinical goals with corporate objectives.
• Provide medical and scientific leadership across all clinical development activities, including preclinical-to-clinical transitions, clinical trials, and regulatory submissions.

Clinical Trial Oversight:

• Oversee the design, planning, and execution of medical device (and future drug) clinical trials, including patient recruitment, data collection, and outcome assessment.
• Ensure that all clinical trials are conducted in compliance with regulatory standards, including FDA, EMA, and ICH guidelines.
• Monitor trial progress and ensure high-quality data generation and timely delivery of key milestones.

Regulatory & Compliance:

• Lead the preparation and submission of clinical and regulatory documents, including De Novo/PMA applications, Investigational New Drug (IND) applications and NDA applications.
• Serve as the primary medical liaison with regulatory agencies, including the FDA, EMA, and other global health authorities.
• Ensure the company adheres to ethical and legal standards in clinical research and medical device/ drug development.

Patient Safety & Medical Monitoring:

• Provide oversight of patient safety and risk management in clinical trials, ensuring adherence to pharmacovigilance protocols.
• Serve as the primary point of contact for medical monitoring during trials and post-market safety assessments.

Collaboration & Stakeholder Engagement:

• Collaborate with internal teams, Plan A’s Medical and Scientific Advisory Boards, Key Opinion Leaders (KOLs), academic institutions, and external partners to advance clinical programs.
• Engage with the Urology community and patient advocacy groups to ensure alignment of clinical programs with patient needs.
• Prepare manuscripts on clinical trial results for publication in leading journals.

Team Leadership & Development:

• Lead and mentor a multidisciplinary team of clinical, regulatory, and medical professionals.
• Build and manage relationships with Contract Research Organizations (CROs) and other external clinical partners.

Qualifications:

• At least 10 years’ experience in a pharmaceutical (ideally several years in a medical device) company in a Clinical and/or Regulatory leadership role.
• Experience designing clinical trials, designing safety assessments (including preclinical plans) and preparing regulatory submissions (FDA, HC, EMA and global authorities).
• Extensive firsthand experience successfully communicating with regulatory bodies (FDA, HC, EMA and global authorities).
• Good communication and leadership skills
• Strong work ethic and ability to work within a fast-moving corporate environment
• Experience preparing publications in leading journals

Education:

• MD required, with board certification in urology or a related field preferred.
• Advanced training in clinical research or drug development is a plus.

Experience:

• 10+ years of clinical development experience in pharmaceutical, ideally medical device, companies, with a track record of success in leading clinical trials to approval.
• Previous CMO or senior medical leadership experience in a medical device, pharmaceutical, or biotech setting.
• Extensive experience in regulatory interactions with the FDA, HC, EMA, and other global health authorities.

Skills & Competencies:

• In-depth knowledge of clinical trial design, therapeutic development, and regulatory requirements.
• Strong leadership, decision-making, and strategic thinking skills.
• Excellent communication and presentation skills, with the ability to convey complex clinical information to both scientific and non-scientific audiences.
• Proven ability to work in a dynamic, fast-paced environment and lead cross-functional teams.

Benefits & Compensation:

• Base Salary: $250,000/yr - $350,000/yr (Exact compensation may vary based on skills and experience.)
• Competitive executive bonus structure.
• Equity participation.
• Comprehensive healthcare benefits.
• Opportunity to drive the development of breakthrough therapies in male contraception.

For more information, please visit nextlifesciences.org