Mitsubishi Tanabe Pharma

Medical Director, Medical Affairs

Job Locations US-NJ-Jersey City
Job ID
2020-1430
# of Openings
1
Category
Medical Affairs

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

With the recent FDA approval and availability in the U.S. of RADICAVA® (edaravone) MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients. 

 

The Medical Director, Medical Affairs will be responsible in developing and overseeing the execution of Medical Affairs programs in US that support pre-approval, marketed, and late development products and compounds with a focus in rare diseases. 

This individual will play an integral role in supporting the Medical Affairs team, as well as appropriate cross-functional initiatives such as providing clinical and disease state expertise and product (compound) knowledge to support evidence generation. The Medical Director, Medical Affairs will serve on the promotional and non-promotional program review committees, offer medical input upon request to assist in the development of promotional materials, and on other internal activities leveraging their scientific and clinical expertise as well as their knowledge of best practices in Medical Affairs. This role is based in the North American Headquarters and will report directly into the Sr. Medical Director, Medical Affairs.

Responsibilities

  • In collaboration with the VP Medical Affairs and Sr. Medical Director, propose strategic medical affairs plans to support programs in the US for pre-approval, marketed, and late development products and compounds with a focus in rare diseases
  • Assist in creating Medical and Scientific programs that are scientifically and clinically sound, meet the needs of the medical and patient communities or other constituencies, and be executed in compliance with applicable laws, regulations, and company policies.
  • Plan and oversee approved or required activities including but not limited to Scientific Communications, Life Cycle Management activities, and other programs to apply medical input.
  • Assist in developing and managing relationships of US Key Opinion Leaders (KOLs).
  • Represent Medical Affairs on promotional and non-promotional medico-legal-regulatory review (PMRC) committees; and provide content expertise on other internal initiatives or work groups, as needed.
  • Develop and maintain excellent working relationships with both US and global Clinical Development, Marketing, and Regulatory functions, ensuring seamless communications and provision of up to date scientifically accurate clinical information to external and internal sources.
  • Maintain scientific, clinical, and therapeutic expertise in the company’s immediate areas of such as ALS.
  • Represent the company by speaking at medical meetings, meetings with national or regional managed care accounts, scientific organizations, and conventions,
  • Represent Medical Affairs & MTPA in external settings such as medical congresses, and company-sponsored scientific advisory meetings.
  • Lead the Medical Plan development in collaboration with other medical cross-functional partners.
  • Completes all company-based and job-related training as assigned by MTPA within the required timeline.
  • Additional duties as assigned by MTPA management.

Qualifications

  • MD/DO with specialty training related to job function, and experience in Neurology or Rare Diseases preferredA
  • Neurologist, ideally with subspecialty in Neuromuscular Disease and US fellowship training OR MD with 5+ years’ experience within the pharmaceutical industry including 3 years in an in-house Medical Affairs role with demonstrated ability to mentor/develop staff.
  • Ability to develop/maintain credible relationships with top tier KOL experts; existing network of relationships in Neurology or Rare Diseases is preferred.
  • Neurologist, ideally with subspecialty in Neuromuscular Disease and US fellowship training OR MD with 5+ years’ experience in within the pharmaceutical industry including 3 years in an in-house Medical Affairs role
  • Strategic thinker who can clearly anticipate future needs/trends and develop and drive appropriate tactical plans to capitalize on that vision.
  • Demonstrated knowledge of regulations governing promotional activities coupled with sense of ethics, integrity and commitment to patients/customers.
  • Highly developed interpersonal, influencing and leadership skills. 
  • Polished presentation, instructional and oral/written communication skills; adept at conveying scientific information in simple terms.
  • Excellent planning and organizational skills, demonstrated independently as well as within cross-functional teams. 
  • Proven ability to effectively manage relationships with cross-functional teams in a matrix organization and with external groups; demonstrates strong customer service orientation. Proven supervisory skills are preferred.
  • Well-organized and skilled at managing multiple projects to timeline and budget
  • Self-starter, hard-working and independent.
  • Maintains optimism and energy in the face of change and adversity; proven ability to collaborate and problem solve.
  • Must embody the MTPA’s values of Respect, Communication, Teamwork, Drive for Results, Accountability, Development, Agility, and Integrity
  • Must be able to travel 30%-40% domestically and internationally for business and project meetings as required

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