Executive Director, Global Medical Affairs, Nephrology& Immunology

Job Summary

The Executive Director, Nephrology/Immunology, Global Medical Affairs (GMA) is a key contributor and member of the Global Medical Affairs Leadership Team, reporting to the VP, Global Medical Affairs. Maintains key accountability for all GMA roles dedicated to the Nephrology/Immunology therapeutic area including medical strategy (late and early assets), global medical communication strategy, medical information, and field medical. Works cross-functionally with both US and global counterparts in commercial, market access, payer value, early development, clinical development and others to create and execute strategic asset plans. Leads the strategic generation of scientific data and the consistent and accurate scientific communication about Otsuka’s nephrology and immunology products in the US and globally.

Job Description

• Oversees global medical affairs planning and activities in cross-functional collaboration with other US and global functions, while working closely with medical excellence and operations.

• Responsible for annual data gap analysis to develop and evolve the product data generation plan for each nephrology or immunology asset through its lifecycle.

• Responsible for the global evidence generation review process to harmonize the global Phase IIIB and IV programs, including Investigator Sponsored Studies and non-interventional studies

• Oversee core content development, including medical information in collaboration with the communication strategy lead for nephrology and immunology

• Ensures that clinical trials include outcomes of interest to patients and fulfilling the medical needs in the therapeutic area.

• Oversees communication strategy plans for both the therapeutic area and each asset in collaboration with the communication strategy lead, including creating the Global Publication Plans for each nephrology/immunology asset.

• Acts as a driving force in the public dissemination of product related data.

• Ensures that both US and regional offices/affiliates (Europe, Canada, and International) are properly cognizant of all product related data and organizes coordination of medical activities across all regions.

• Oversees development of manuscripts, presentations, US and international symposiums, and posters.

• Serves as a therapeutic area thought leader and interacts with experts in the field to obtain feedback on clinical aspects of US and global products and new data generation, interpretation and dissemination

• Provides input into regulatory documents, including product labeling

• Participates in the evaluation of potential in-licensing candidates

• Leads the nephrology field medical team

• Establishes SOPs and sets standards to ensure that the medical function operates effectively and efficiently and that all medical communications are accurate and of high quality.

• Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating Procedures (SOPs).

Qualifications

Required:
MD, PhD or PharmD with exceptional leadership experience in the Medical Affairs area

• Minimum of 10 years of experience in Medical Affairs

• At least 5-7 years of demonstrated supervisory experience with the ability to lead and motivate others

• Requires extensive understanding of the company's products, clinical development, commercialization strategy, the competition, and the pharmaceutical industry in general.

• Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.

• Skilled in managing change and influencing people

• Excellent communication and interpersonal skills

• Ability to travel up to 30% of time

• Experience or expertise in Nephrology and/or Immunology a must