Director Medical Affairs

US-NJ-Princeton
Requisition ID
2017-9818

Overview

Our Mission: Otsuka-people creating new products for better health worldwide

 

Welcome to Otsuka

These are exciting times for all of us at Otsuka in the U.S. We not only have a rich portfolio of products making real differences in areas of unmet medical need, but we also have many investigational products at various stages of development. Our work in digital medicine promises to pioneer a new behavioral healthcare paradigm, and our commitment to patients persists in our transformative support programs.

 

Otsuka-People

Turning vision into reality requires passion, leadership, dedication, diversity of thought, collaboration, and perseverance. Otsuka-people have these qualities in abundance, and we support them by providing a dynamic work environment that encourages them to explore ideas, seize opportunities, and grow in meaningful ways. Our passionate leadership and unique culture, combined with access to continuing education, a unique workspace, and top-of-the-line 401(k) retirement savings plans with matching contributions, among other benefits, make Otsuka a truly different place to learn and grow.

Responsibilities

Serves as the lead providing Medical Affairs support for the oncology franchise. Responsibilities include providing medical input to the commercial team, ensuring medical veracity of promotional materials, ensuring appropriate data-based positioning of the product(s) in the marketplace, and providing medical/data training to field medical affairs and account executives as needed. 

 

  • Serves as member of development and brand teams for Otsuka oncology products 
  • Works with marketing and legal departments to review promotional and other product materials in accordance with FDA and other applicable regulations 
  • Serves as a source of medical expertise on Otsuka clinical trials for in-house customers 
  • Proactively acts as a liaison between the commercial group and the global medical and clinical development organizations
  • Develops annual publication plan and prepares (or organizes preparation of) manuscripts, presentations, and posters
  • Interacts with experts in the field to obtain feedback on products and advice regarding further development
  • Provides input into the creation of marketing materials and ensures data is accurately and effectively communicated
  • Provides input into regulatory documents
  • Reviews continuing education and unrestricted grants as well as investigator-sponsored studies proposals
  • Reviews safety information generated by Pharmacovigilance, takes part in discussions regarding interpretation of safety findings, and assists with periodic and other safety reports
  • Participates in creation of materials for field medical liaisons, participates in training of MSLs
  • Works with HEOR department for creation of dossiers and to provide direction for planning and execution of HEOR research
  • Coordinates with sales management to provide training to sales staff
  • Provides direction for medical information specialists
  • Participates in extramural conferences and scientific meetings to 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
  • May be asked to provide input on feasibility of a drug candidate during pre-clinical and clinical studies
  • May participate in the evaluation of potential in-licensing candidates

Qualifications

Knowledge

  • Requires extensive understanding of oncology products, commercialization strategy, regulatory issues, and the pharmaceutical industry in general. 
  • Maintains a current awareness of new drug developments in targeted therapeutic areas.
  • Strong scientific background and solid understanding of the pre-clinical and clinical development processes.
  • Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.

 

Skills

  • Ability to interpret scientific data and calculate potential commercial value and financial impact. 
  • Skilled in managing people and getting points across in matrix environment
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
  • Demonstrated ability to effectively present scientific information (written information and oral presentations) 
  • Excellent communication and interpersonal skills
  • Thorough knowledge of promotional regulations and pharmaceutical promotion standards
  • Knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals
  • Deep understanding of US pharmaceutical safety reporting and surveillance


Education & Experience

  • MD or PhD, PharmD with extensive demonstrated experience will also be considered
  • Minimum of 8 years of experience in the industry, with at least 5 years in the oncology field in the US Medical Affairs role
  • Having had a prominent role in the launch of a product in the US market a strong plus

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