Job Type: Full-time
Location: Bethesda, MD
Job Title: Associate Director / Director, Clinical and Medical Affairs

Company Overview:
Pocket Naloxone Corp. (PNC) is a startup pharmaceutical company based in Bethesda, MD. The company is currently developing a nasal OTC naloxone asset and has several pipeline candidates also utilizing the same nasal delivery platform. The company is committed to help prevent families from losing loved ones needlessly to opioid overdoses by making its flagship naloxone product widely available at a low price point, after receiving regulatory approval.

Position Overview:
We are currently seeking a highly qualified and experienced Associate Director / Director of Clinical and Medical Affairs to join our team. The position will play a crucial role in overseeing and directing all aspects of clinical programs for our 505(b)(2) portfolio. This position will be responsible for planning, executing, and managing clinical studies to ensure the highest standards of patient safety, data integrity, and regulatory compliance, and would support commercialization efforts by serving as a subject matter expert in educational initiatives. With
expansion, it is anticipated that the clinical and medical roles would become standalone positions and the company is seeking an individual who is interested in joining a startup and helping to build out the team.

Responsibilities:

1. Clinical Trial Management:

• Develop and implement comprehensive clinical trial strategies and plans for 505(b)(2) drugs, in alignment with business objectives and regulatory guidelines.
• Oversee the planning, initiation, execution, and completion of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
• Manage clinical trial operations, including site selection, investigator recruitment, patient enrollment, and monitoring of trial progress.
• Collaborate with cross-functional teams, including research and development, regulatory affairs, and medical affairs, to ensure seamless execution of clinical trials.
• Monitor / review and analyze trial data, identify trends, and provide insights for decision-making and strategic planning.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, local regulations, and ethical standards throughout the clinical trial process.
• Conduct risk assessments and implement risk mitigation strategies to proactively address potential challenges and ensure trial success.

2.  Medical Affairs Leadership:

• Provide medical and scientific expertise to support clinical trial design, protocol development, and study feasibility assessments.
• Collaborate with the commercialization team to develop strategies and educational materials for clients, healthcare professionals, investigators, and study site staff.
• Participate in scientific advisory boards, investigator meetings, and conferences to stay updated on industry trends, clinical research advancements, and competitive landscape.
• Build and maintain strong relationships with key opinion leaders, investigators, and external stakeholders to facilitate clinical trial collaborations and knowledge exchange.
• Lead efforts in publishing and disseminating scientific and clinical data.

3. Regulatory Compliance & Submissions:

• Ensure compliance with relevant regulatory requirements, including FDA guidelines, ICH guidelines, and other applicable regulations.
• Work closely with the regulatory affairs team to prepare and review eCTD and other documents, including protocols, investigator brochures, informed consent forms, clinical study reports briefing packages, module summaries and other documents for Agency submissions.
• Coordinate with regulatory authorities and ethics committees for protocol approvals and study-related submissions.

Qualifications and Skills:

• MD, DO, PharmD, or PhD in a relevant scientific discipline is required.
• Minimum of 8-10 years of experience in clinical trial management, with a strong emphasis on 505(b)(2) drug development desired.
• In-depth knowledge of clinical trial design, execution, and management, including regulatory requirements and GCP guidelines.
• Proven track record of successfully leading and managing pharmaceutical clinical trials from start to finish.
• Experience/track record with managing KOL relationships.
• Experience with clinical, medical and scientific presentations and publications.
• Excellent leadership and team management skills, with the ability to motivate and inspire a diverse team of professionals.

Travel:
Ability to travel as needed.

Other Information and Benefits:
Pocket Naloxone Corp. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Employees are eligible to receive health, vision and dental insurance and participate in the 401k plan with a company funded 5% match. The Company provides life and short and long-term disability insurance to employees. Full-time employees receive 21 days of paid time off and 20 company holidays a year! If you are a results-driven and highly motivated individual with a passion for healthcare, we encourage you to apply!

Send your resume or CV to recruiting@pocketnaloxone.com.

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