• Sr. Director, Medical Affairs

    Intra-Cellular Therapies, Inc (Bedminster, NJ)


    Benefits Offered

     

    401K, Dental, Life, Medical, Vision

     

    Employment Type

     

    Full-Time

     

    _“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”_

     

    Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA®), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

     

    The Senior Director, Medical Affairs supports the Medical Affairs department in the development and the execution of the Strategic Medical Plan (SMP). They perform the relevant tasks to ensure successful implementation of the SMP and proper product support. They are involved on projects concerning marketed products, but also products in (and entering) the clinical phase of the development pipeline.

    Responsibilities:

    Tasks include but are not limited to the Following Areas of Medical Operations:

    + Medical/Legal/Regulatory Review

    + External Scientific communications

    + Scientific Publications

    + MSL support

    + Medical Information

    + Phase IV Plans and Studies

    + IIT plans and strategies

    + Medical Education

    + Health Economics

    Tasks as they relate to Medical Operations (including, but not limited to):

    + Regulatory Review of Marketing Materials (from a Medical Aspect) for OPDP submission

    + Development of scientific presentations for external use

    + Publication Plan development

    + Scientific Publication drafting and review

    + Standard Medical Letters for Medical Information Purposes

    + Review of Medical Information Reports (and development of follow-up strategies to knowledge acquired from them)

    + Scientific Product FAQs

    + Phase IV Plans and Protocols

    + IIT reviews and approvals

    + AMCP dossier development

    + Health Economics plans and projects

    Tasks as they relate to cross-departmental activities and support, including (but not limited to):

    + Representing Medical Affairs in Development meetings

    + Assisting Commercial Colleagues in the creation of scientifically accurate and appropriate materials for outside use

    + Providing input into Clinical Study Reports, as needed

    + Creation and review of training materials for the sales force as well as other internal team members. Perform training activities as needed

    + Performing data review

    + Working with CMC to assess potential risks of product complaints

    + Work with Market Access to develop Product Value Propositions

    + Target Product Profile creation and review (for products in development)

    + Periodic and ad-hoc review of product labeling in response to FDA comments, in conjunction with sNDA review, and in other cases as needed

    + Ensuring alignment amongst relevant functional groups

    + Review of report from Drug Safety/Pharmacovigilance, as needed

    + Preparing for and participating in product Scientific Advisory Boards for products both marketed and in development

    + Complete all company and job-related training as assigned within the required timelines.

    Job Requirements:

    + Relevant science degree (i.e., PhD, PharmD, MD; Master’s degree considered based on experience)

    + Experience in relevant Therapeutic Area(s) preferred

    + Minimum 12 years of overall work experience or equivalent combination of experience and education

    + Minimum 10 years of experience in the pharmaceutical/device industry preferred (preferably in Medical Affairs and/or Clinical Development, experience with product launches also preferred)

    + Ability to travel up to 35% (depending on company priorities)

    + Ability to work in a team setting as well as function as an individual contributor

    + Ability to communicate effectively

    + Ability to be flexible in an ever-changing environment

    + Ability to work efficiently and under tight timelines

    + Ability to think strategically and be able to anticipate problems before they occur

    + Ability to be proactive in finding solutions to issues

    + Proficient in Microsoft office (Word, Excel, PowerPoint)

    + Must be able to perform all essential functions of the position, with or without reasonable accommodation.

    + Duties, responsibilities, and activities may change at any time with or without notice

    + Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

     

    Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

    \#ITCI

    Sr. Director, Medical Affairs Base Salary range $210K - $270K