Posted to MedZilla on 9/18/2019


Takeda Pharmaceuticals

US-MA, Global Medical Unit Head, Complications of Prematurity (COP/TAK-607) SR0039562-MZ


 
 

Primary Duties

  • Leads development and execution of multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall PVPS strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
  • Serves as the global expert within Takeda in support of the product/disease area incl. the respective charitable strategy
  • Leads the global medical team for the product/disease area
  • Responsible for development and in-year implementation of global medical plan and oversight of strategy implementation regions
  • Develop and management of the Global medical budget
  • Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
  • Establishes appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
  • Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between GMA personnel and external stakeholders

Responsibilities:

  • Lead development of medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • Oversee development of in-year global medical tactical plan and budget for the global initiatives
  • Lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
  • Leads the collaboration with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution.
  • Participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to GPT
  • Define Global GMA team goals and key performance metrics
  • Lead the Global Medical Team
  • Collaborate with Legal, Compliance and Regulatory and Medical Training to ensure understanding and adherence of global medical team to Takeda and external policies and regulations
  • Coordinate with Head of Medical Affairs (RMD), Global Medical Team and Global Medical Training to define and address global medical team training and professional development needs and training needs related to the product/disease area
  • Mentor and develop global medical team
  • Monitor team performance in terms of goals and delivery of medical plans and identify areas for development
  • Oversee and manage in-year implementation of global medical strategy

Lead and guide implementation of strategy, potentially including:

  • Providing physician leadership for scientific communications, including standard responses and publications
  • Planning, designing and managing global and overseeing regional/local medical Advisory Boards
  • Providing medical review and approval of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
  • Leading design and execution of clinical studies (phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
  • Leading completion of regulatory obligations
  • Monitor and communicate progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements
  • Overseeing medical review and approval of promotional and meeting materials
  • Interaction with external stakeholders in alignment with customer needs and medical strategy
  • Act as a senior company representative with external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities
  • Establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
  • Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
  • Establishes appropriate strategic partnerships with KOLs in areas of scientific interest
  • Represent Medical Affairs at internal and external meetings
  • Present data on product / therapeutic area
  • Maintenance of knowledge base
  • Serve as a key medical resource on the disease area and on specific products
  • Maintain a high level of expertise on the disease area
  • Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and Takeda policies related to all medical activities
  • Develop, conduct, or participate in therapeutic training programs for Takeda internal departments

Education and Experience Requirements:

  • A medical degree is required
  • >8 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure.
  • Experience in medical affairs is required
  • Experience leading teams at the brand or disease area levels in country, regional or global organizations is required
  • Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) is preferred
  • Experience in clinical development is preferred
  • Experience in the disease area of interest ie. neonatology through clinical experience, biopharmaceutical experience or education is preferred

Key Skills, Abilities, and Competencies:

  • Demonstrated business acumen
  • Ability to think strategically from a medical perspective about how to medically appropriately support the growth of a brand
  • Ability to work in a Global environment, across diverse cultures
  • Ability to successfully influence and negotiate across and outside of the organization
  • Ability to collaborate appropriately with Commercial functions
  • Ability to represent company s interest in scientific forums as needed
  • Strong clinical skills and understanding of clinical trial design
  • Excellent written and verbal communication skills
  • Ability to lead teams and drive initiatives without direct line management authority
  • Results orientation and accountability
  • Good analytical skills as applied to medical, scientific and technical information
  • Unquestioned ethics are a must

Complexity and Problem Solving:

  • Development of Medical and pipe-line R&D strategy for the product/disease area
  • Representation of GMA and contribution to a range of internal functional groups
  • External stakeholder management and engagement
  • Development and management of the global medical affairs budget

Internal and External Contacts:

  • Position is accountable to VP, Global Medical Franchise Head (RMD)
  • Internal: Member GPT (TAK-607)
  • Internal: GPT, regional commercial Leads, Field Medical effectiveness and Team, regional Medical Affairs team, Medical Function teams, Rare Disease TAU incl. Therapeutic Area Clinical Development Lead and Global Clinical Operations, Regulatory, Compliance, LegalMember of Therapeutic Area Lifecycle management (LCM) team
  • Leader of the Global Medical Team
  • External: Key academic, professional, regulatory, policy, patient advocacy leaders, strategic vendor partners

Other Job Requirements:

  • Availability to travel approximately 30%-40% of time
  • Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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