Head of Medical Affairs (Project Management)

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.  

Hybrid  

Position Summary: 

​​The Head of Medical Affairs will be responsible for providing medical expertise to support clinical development programs by interfacing with internal and external medical experts, internal support functions and professional organizations.  The individual will be responsible for working with the TOI, TCAN & TOE Executive leadership team, R&D leadership, and Taiho Pharmaceuticals (TPC) leadership to meet regional MA needs and facilitate development of Global medical affairs capabilities of for an expanding commercial portfolio and evolving product pipeline globally.  The candidate must be able to contribute to a strategic vision for the future and deliver on existing time sensitive projects.  Has accountability for all aspects of Medical Affairs and for co-chairing Global Medical Affairs Committee (GMAC). 

Performance Objectives: 

• Represents Medical Affairs on GDPM and Product Development Teams to provide insight on products, patient treatment trends and scientific activities within Hematology and Oncology. 
• Leverage product data, medical and scientific insights to inform and develop strategies and medical plans for pre-Launched and Launched products.
• Oversight of the Medical Field team including MSLs (Medical Science Liaison) and Health Systems team (HST), oversight of exchange with the Scientific Leaders (SL's) and response to unsolicited questions about marketed products and discuss pipeline programs, while collecting insights. Drive the Scientific Leader (SLs) identification and relationship and trusted partnership development and insights collation process. 
• Assists in the selection of key external experts for Evidence and Value development (EVD) and maintain key relationships.
• Oversight of the Real World Evidence and Value development team to define an integrated medical and value plan and exchange with key decision makers. Works in concert with Market Access to develop evidence and value-based initiatives.
• Develop plans for key National and Regional medical meetings participation globally.
• Develops processes to support Independent Medical Education programs (IME) including CME and non-CME).
• Develops and delivers scientific and medical presentations, oversight of advisory boards and participates in investigator meetings.
• Interfaces with Taiho US, TCAN and TOE key Scientific Leaders (SLs) and supports interactions with advocacy organizations.
• Provides due diligence support for business development projects, clinical development pipeline strategy and clinical trials, including Patient reporting outcomes and endpoints that result in value add to patients and coverage & reimbursement.
• Develops strategy and implements external research programs (IITs and collaborative studies). Participates in the development, execution, and management of Investigator Sponsored Trial (IST) strategy for all products and pipeline.  Works closely with NCCN on ORPs.
• Responsible for facilitating publication strategy and plans (Clinical, Medical and EVD), medical communication and medical information planning and execution. Collaborates across the organization to create publication plans for each clinical program and manages their execution using GCP guidelines
• Work collaboratively with the Clinical Development, Product Development, Regulatory Affairs, Commercial, Legal and Finance departments.
• Coordinates activities with Alliance partners, TPC, TPAC, TPOC, TCAN and TOE Medical Affairs, as appropriate.
• Maintains Medical Information call center for external medical inquiries and develop standard response documents for response.

Education/Certification Requirements: 

• MD degree is required

Knowledge, Skills, and Abilities: 

• M.D. with board certification and/or board eligibility in medical oncology strongly preferred.
• Requires 10+ years of industry experience in medical affairs.  In depth expertise in at least several of the responsibility areas listed above with a strong desire to acquire experience across all aspects of medical affairs.  Preference for candidates who have product launch experience.
• Experience in evidence-based approaches to value creation is a plus
• Strong working knowledge of the drug development process in the USA is required. Global oncology clinical development experience is preferred.
• Direct work experience with US and/or Global Regulatory authorities is highly preferred.
• Highly detail and quality oriented.
• Excellent presentation skills.
• Ability to persuade and negotiate with project team members and senior management.
• A positive attitude, flexibility and a proactive thought process.

The pay range for this position at commencement of employment is expected to be between $340,850 - $422,450 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.  

  

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.