The position of Medical Director of Clinical Research and Development is primarily responsible for clinical development programs related to generic products and the expansion of the pipeline. The company has several unapproved Multisource generic products that require prioritized clinical strategic plans aligned with regulatory activities for approval of use in targeted populations. Additionally, seeks pipeline expansion for a branded product and new products via an expanding Business Development program.
Essential Duties and Responsibilities
Strategic planning for pharmaceutical product development inclusive of
Target patient population evaluation, clinical development program design, protocol design, endpoint selection, clinical utility, current standard therapy, competitor identification, and regulatory agency interaction.
Working with cross-matrix teams for integrated clinical programs aligned with regulatory approval pathways.
Development, plan, and implementation of clinical research programs and trials.
Lead role in clinical projects for medical and scientific soundness; provision of medical input to project teams.
Review of pre-clinical programs to ensure adequacy and scientific rigor (ie., bioequivalence studies).
Development, management, and approval of the scientific methods for design of clinical protocols, case report forms, guidelines, study reports, and manuscripts.
Provision of protocol and/or therapeutic area training for the internal and external project teams.
Assistance in investigator identification and selection.
Development and review of informed consent documents; evaluate subject eligibility for clinical trials.
Assurance of subject safety, adequate reporting, and coding of adverse events in clinical trials.
Oversee the generation of Medical Monitoring/Safety Plans.
Ensure timely updates to protocols, Investigators Brochures, and product labels as required.
Participation in and/or presents at Investigator Meetings.
Interactions with Contract Research Organizations (CROs), healthcare consultants, and investigators.
Oversee and participate in clinical study report writing, critical medical review, and assessment of written documents.
Business Development, Educational Programs, and Business Administration
Medical lead in the execution of business development opportunities which support overall strategic and business objectives.
Liaise with business partners or clients for provision of medical/scientific expertise and analyses in support of new business ventures.
Provision of education to potential project teams regarding medical background for proposed projects.
Deliver/oversee business development presentations.
Deliver/oversee educational programs for health care providers.
Participation in administrative activities as required by the Vice President of Clinical Operations in order to maintain business standards in compliance with SOPs and local guidelines.
Attend/participate in training lectures, symposia and conferences in order to maintain current license and maintain and promote Company’s therapeutic area(s) of expertise.
Qualifications and Requirements
· Medical degree (M.D., DO) or PhD with subspecialty training; United States (US) medical license preferred.
· At least 4 years’ experience in pharmaceutical business development, academic research, or a clinical research organization (CRO), with evidence of successful ongoing career development.
· Excellent oral and written English communication skills.
· Able to function in multiple therapeutic areas with prior management experience as evidenced by previous direct reports.
· Experience as direct medical liaison with the US Food and Drug Administration is desired but not required.
· Ability to make decisions independently and with appropriate input.
· Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, and Medical Affairs.
· Must have a valid U.S driver license and be able to operate vehicles safely.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
Physical Environment and Physical Requirements
· While performing duties of the job, the incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
· Employee must be able to occasionally lift and/or move up to 15 pounds.
1. Generics experience due to that process being different than prescription approval process Must have experience in drug approval process
2.Injectables ideally but if generics may be ok
3. No specific therapeutic area
4. Will have direct reports
5. Enlicensing or licensing of compound and projects experience
Candidate will be working with products in development and on market for FDA approval process.