Director
Job Description
The Director, US Medical Affairs - CNS will provide medical leadership for a first in class new indication for an already successful flagship CNS brand at Otsuka. The position will report to the US Medical Affairs Senior Director/CNS TA lead. This individual will take a leadership role for the execution and implementation of the Medical Affairs strategy in support of a growing brand in neuropsychiatry. He/she will ensure a scientifically sound and medically relevant voice for the company through medical representation on relevant cross-functional teams, and collaboration with partner company and global affiliate. They may take a leadership role for the execution of medical affairs research and will also assist in the evaluation and support of investigator-initiated trials in their therapeutic area. He/she will serve as a therapeutic area expert in content creation, strategic and tactical discussions, and presentations with internal colleagues, as well as external experts and investigators.
The role comprises, but may not be limited to, the following responsibilities:
- The Director of US Medical Affairs leads a cross-functional team to develop and execute a Medical strategic plan for a specific indication within the Rexulti franchise.
- Serves as member of cross-functional teams, as medical expert.
- Plan and lead advisory boards to gather insights as needed
- Develop US data generation strategy (ph4, IST, post-hoc analyses) and lead execution
- May work with marketing and legal departments to provide feedback on promotional and other product materials in accordance with OPDP regulations; Escalation point for core medical reviewer
- Provides input as medical expert to all aspects of brand across the entire product lifecycle in the U.S.
- Reviews clinical results and develops appropriate communication plans (i.e., publications, posters, presentations, PR, etc.)
- Responsible for disease state education strategy and plans
- Reviews grant requests as needed
- May coordinate with sales management to provide training to sales staff
- Identifies and develops relationships with external consultants, medical experts, investigators and vendors
- Provides direction and technical assistance for medical information specialists and field medical personnel
- Participates in extramural conferences and scientific meetings to present clinical information and maintain awareness of research in the field
- Keeps abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to clinical staff and other project team members, as needed
- Support and participate in HEOR/RWE activities and ensure alignment to strategy
- Provide medical materials (slide decks, documentation, FAQs etc.) in support of medical field personnel and other brand needs, with vendor support as needed
- Reviews safety information generated by Pharmacovigilance, takes part in discussions regarding interpretation of safety findings, and assists with periodic and other safety reports
- Responsible for assigned budget
- As needed, assists Sr. Director, Medical Affairs in department or therapeutic area initiatives
Qualifications/ Required
- 5+ years experience in pharmaceutical industry
- Familiarity with Biostatistics - Excellent communication and interpersonal skills
- Knowledge of OPDP promotional regulations and pharmaceutical promotion standards
- Familiarity with CDER/CBER regulations regarding evaluation and approval of pharmaceuticals
- Understanding of US pharmaceutical safety reporting and surveillance
- Proven track record demonstrating ability to adapt to evolving pharmaceutical landscape
- 25-40% travel to Princeton, NJ (1-2 times a week)
Preferred
- Pharmaceutical industry experience in the relevant therapeutic area (CNS) highly preferred.
- Pre-launch/Launch experience
Educational Qualifications
- M.D, PharmD., or PhD