Chief Medical Officer (CMO)

Job Type: Full-time

Location: Remote/Bethesda, MD

Job Title: Chief Medical Officer (CMO)

Company Overview:

Pocket Naloxone Corp. is a mission-based start-up pharmaceutical company in the Washington DC metro area. The company is currently developing a nasal OTC naloxone asset and has several pipeline candidates also utilizing the same nasal delivery platform.

Position Overview:

The Chief Medical Officer (CMO) has the responsibility to provide a high level of medical expertise supporting the Company, including in areas of clinical development, portfolio and lifecycle management, medical affairs, scientific communications, and pharmacovigilance.

This role reports to the Chief Executive Officer, and may be performed remotely, but preferably within EST zone, with regular travel to the Bethesda, MD Headquarters.

Responsibilities:

· Provide medical expertise in the development of Clinical Development Program (CDP) pipeline and portfolio development

· Lead clinical and device studies and activities in coordination with the clinical development team that support the CDP as needed

· Provide clinical guidance and support education to internal and external stakeholders

· Lead the development of strategic plans for scientific communications (including data dissemination, publication plans, congress plans, etc.) for the company working with internal and external (KOLs, etc.) and execute the plan to external stakeholders (KOLs, key associations, government agencies, etc.)

· Develop a network of medical KOLs for the company to tap for expertise as needed in the CDP and pipeline product development

· Deliver strong scientific, medical and drug development leadership for the company and function as a key company liaison with KOLs, Scientific/Medical Advisors, DSMBs, Board of Directors, Investors

· Lead, develop, and execute medical affairs strategy, medical information strategy (and health economics as needed)

· Ensure that the highest quality, scientifically and medically accurate, and fair-balanced medical data is contained in all Company generated pre-approval scientific communications materials and post-marketing commercial/marketing materials, scientific publications, medical information letters and responses

· Represent the Company to outside medical/scientific experts via participation in scientific congresses, and other medical affairs related activities

· Keep abreast of current medical/scientific progress and actively develop and maintain relationships with outside experts aligned with the scientific/medical objectives

· Provide insight to pipeline determination in clinical feasibility and translate findings from research and medical community into clinical development opportunities

· Assume responsibility for and/or provide oversight for review and evaluation of information relevant to the safety of PNC drug products and act as monitor or provide oversight of monitors during the conduct and progress of clinical investigations

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Qualifications and Skills:

· MD or equivalent with active board certification in emergency medicine, internal medicine, addiction medicine or other related sub-specialization. Current clinical practice experience in prescribing and using Naloxone is desired

· Prior experience with drug development and multiple years of experience across clinical/medical affairs, clinical operations, biometrics, and pharmacovigilance is desired

· Knowledge of relevant FDA regulations and guidelines. Familiarity with Health Canada, EU and other governing body regulations and guidelines is desired

· Must have a good working knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.

· Ability to understand and communicate scientific and medical information to both internal and external networks, that support the scientific and business strategy of the Company’s product(s)

· Excellent verbal and written communication skills

· Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members

· Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines

· Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Travel:

Ability to travel as needed.

Other Information and Benefits:

Benefits include health, vision and dental insurance, 401k plan with a company funded 5% match, and FSA. The Company also provides employer funded life/ADD and short- and long-term disability insurance to employees. In addition to 21 days of PTO, full-time employees also receive a generous number of paid company holidays per year (for 2024 PNC is allocating 19 paid holidays).

PNC 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.

*WE DO NOT ACCEPT CANDIDATES FROM OUTSIDE SEARCH FIRMS AND RECRUITERS PLEASE*

Powered by JazzHR

h3HUeRjLoQ