Senior Director Medical Information

Location
New York City Metropolitan Area, New York, United States
Posted
Oct 09, 2020
Ref
2011512497
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
OVID THERAPEUTICS

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).

Senior Director, Medical Information
  • Responsible for overseeing and leading medical information globally for all Ovid compounds.
  • Oversees and assist with medical reviews of submitted promotional content.
  • Identify/implement/lead medical information-based projects and may also assist with other projects associated with Medical Affairs such as new product or indication launches.
  • Collaborate with Medical Affairs leadership team on strategy development/execution, and any other projects that may help meaningful support/impact to the Company.
  • Adhere to industry guidelines and prevailing regulations, i.e. GDPR and MDR.


Responsibilities include but are not limited to:
  • Develop and maintain clinical and technical expertise in specific Ovid's therapeutic areas.
  • Establish and maintain a standard answers database by obtaining internal review and approval.
  • Maintain and distribute as appropriate and necessary.
  • Establish infrastructure to support/oversee the development of a Medical Information database and Medical Information SOPs.
  • Stay abreast of emerging scientific literature and clinical trial data, translate the data in applicable knowledge and develop/review scientific materials for key internal and external audiences (healthcare providers and various internal teams such as Medical Science Liaison slide development).
  • Facilitate (with vendor support) intake and triage of inquiries as related to marketed or pre-market products.
  • Prepare/update scientifically balanced responses to unsolicited request for both labeled and off-label indications.
  • Provide verbal and/or written clinical and technical responses to inquiries related to Ovid's compounds in development and marketed when applicable from the health care community, patients, and internal customers.
  • Performs Medical/Legal/Regulatory Review of documents facing external customers (promotional and non-promotional).
  • Support internal groups, including but not be limited to Medical Affairs, Clinical Development, Business Development, Patient Safety, with literature searches, data interpretation, publication procurement, Corporate Library Service access and training.
  • Participate in Medical Information projects, including development of new systems or upgrades of old systems, processes and standard operating procedures.
  • Assist in the development and maintenance of product dossiers.
  • Partner and collaborate effectively with internal and external business partners including Safety/Pharmacovigilance consultants and Product Complaints.
  • Provide support for the Corporate Library System to keep it current.
  • Support product launches as needed.
  • Perform all other duties as assigned.



Minimum Requirements:
  • Doctoral level degree in scientific discipline or applicable health sciences field (e.g., PharmD, PhD, MD).
  • Demonstrated Leadership experience in a team-based organization 5+ years of Medical information experience.
  • 10+ years of Medical information experience
  • Experience creating & growing a Medical Information Department
  • Demonstrated expertise in the review of promotional materials.
  • Demonstrated experience in drafting standard response letters.
  • Demonstrated experience in drug information and knowledge of applicable regulations.
  • Demonstrated experience in process-oriented function in pharmaceutical industry
  • Experience in developing new services and programs.
  • Demonstrated project management experience with a proven record of driving impact.
  • Global experience desired.
  • Experience in creating and implementing training programs.


Skills and Capabilities
  • An ability to think strategically and understand needs for medical content in a Global Medical Information system.
  • Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment; strong analytical and problem-solving skills.
  • Working knowledge of medical information technology systems and an ability to identify the most efficient and effective way to implement new services.
  • Facilitation, presentation and interpersonal communication skills in a variety of formats (such as seminars, workshops, web-based training or podcasts).
  • Strong operational and process ownership skills.
  • Understanding of the global guidance for provision of medical services Knowledge of the IS/IT needs for global development and implementation.
  • Scientific/Medical knowledge and technical skills in medical information provision.
  • Strong ability to effectively collaborate with various roles within the organization.
  • Excellent organizational skills, interpersonal skills, conflict management.


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