Job Type: Full-time
Location: Bethesda, MD
Job Title: Associate Director / Director, Clinical and Medical Affairs
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.
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.
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
- 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.
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 21
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 [email protected]