An executive search firm is looking for a Senior Director, Medical Affairs position within a well known pharmaceutical company located in Northern NJ (company paid relocation). It is an exciting opportunity to join a growing company focused in the Oncology and Infectious Disease therapy areas.
SENIOR DIRECTOR MEDICAL AFFAIRS
Pharmaceutical company located in New Jersey (Company paid Relocation) is seeking a Sr. Director, Medical Affairs. Position will lead Medical Affairs activities supporting company products through developing and delivering innovative and integrated programs and activities in the specified indication. Provide essential support to and work closely with the business organization (Marketing, Marketing Research, Business Development and Licensing, sales) as well as Regulatory Affairs and Clinical Research groups. Develop and implement strategies and tactics to support products throughout their life cycle partnering with Development and commercial teams as appropriate fostering an optimal strategic and operational synergy between medi! cal affairs and the commercial organization. Ensuring that the Medical Affairs activities and programs are conducted within an optimal regulatory compliance framework
-Develop research summaries, publications and presentations arising from studies and other initiatives.
-Serve as Medical expert for company products, providing relevant scientific insight and support, developing and substantiating claim support and providing oversight and medical sign off to all related product messages and copy.
-Coordinate with industry and professional bodies to support commercial, Scientific and regulatory objectives and maintaining proactive communication with colleagues in R&D, Legal and Marketing.
-Participate in tactical and strategic project teams; collaborate with the drug safety team to optimize Pharmacovigilance activities, including evaluation of reports on spontaneous and clinical adverse events and monitoring product labeling.
-Assist in the selection of outside experts and maintaining productive relationships with key opinion leaders in the areas relevant to the business.
-Key role as a consultant in the review of clinical research programs and final study reports for development projects as well as in clinical research programs needed for the support of existing products and claims.
-Provide involvement at an early stage in project planning and recommending the most appropriate medical input for project development plans, early opportunity assessments and preparation for meetings with Health Authority and submission.
-Seek out opportunities to introduce and expand position and influence in the health care environment through appropriate targeted activities with key customers and selective affiliations with key professional organizations.
-Facilitate adherence to ICH, Pharmacovigilance and GCP guidelines and writing and managing department SOP's.
PharmD or MD with 7+ years pharmaceutical industry experience within Drug Development, Clinical Research and or Regulatory Affairs.
Minimum of 3 years Medical Affairs experience with demonstrated understanding of the integration of Medical affairs activities into the commercial environment.
Therapeutic area knowledge within AIDS, Cancer, Nutrition and or Geriatric a plus.
Knowledge of Regulatory guidelines, IND/NDA requirements, procedures and documents.
Well-developed research, data analysis and summarization skills.
Exceptional verbal and written communication skills and accomplished presentation/public speaking skills.
Demonstrated project management and coordination ability.
Strategic planning, leadership and management skills