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Therapeutic Area Advisor, GI

Apply Now Email Me Job ID SR0042480 Date posted 10/03/2019 Location: Sydney, Australia

POSITION OVERVIEW:

This position provides scientific and medical support for a Therapeutic Area(s).  This position acts as therapy and product expert to both internally and externally, providing medical insights and field intelligence to support the development, launch and life-cycle management of Takeda’s products.  

This position may be responsible for creation and execution of the therapeutic area Medical Plan aligned with the Brand Plan, in alignment with Country Medical Director or Line Manager.  
This position will collaborate cross-functionally to develop and execute medically-relevant strategies and tactics as well as provide scientific expertise and training to cross-functional stakeholders as needed.  This position has duel office-based responsibilities (40%) and in-field duties (60%) collaborating with KOLs and other external customers as needed.

RESPONSIBILITIES:

OVERALL

  • Responsible for maintaining a very high level of updated  scientific knowledge and understanding of the overall treatment and healthcare environment in the TA
  • Execute the Medical Plan for the relevant Therapeutic Area(s) for the country, in line with Area / Regional / Global strategies and the Brand Plan
  • Provide input into the development of Brand Plans
  • Establish ongoing relationships with key opinion leaders (KOLs), government officials and healthcare organisations and ensure that significant developments in the field are identified and monitored

STRATEGIC PLANNING

  • Responsible for executing the Therapeutic Area Medical Plan, aligned with both the Brand Plan and the area/regional/ global Medical Plan (where relevant)
  • Provide medical/scientific input into the Brand Plan and is a member of the cross-functional Brand Team
  • Utilise in-field insights to support medical and scientific strategy and business development
  • Provide field-based support from the medical function (as needed) that is aligned with overall corporate goals and objectives

CONTRIBUTION TO ORGANISATION THROUGH SCIENTIFIC EXPERTISE

  • Develop and implement key medical activities (e.g. Advisory Boards, Focus Group Meetings, medical education and peer-to-peer training activities) in line with the Medical Plan
  • Identify educational opportunities that are aligned with Takeda’s medical education strategies
  • Provide clinical presentations and medical information to managed markets and government accounts upon request

CORPORATE GOVERNANCE

  • Contributes to and/or provides medical review of promotional materials for scientific meetings, symposia and other activities, in accordance with applicable Codes of Practice and regulations and Takeda policies, within defined timelines under guidance of Country Medical Director or Line Manager
  • Ensure that the technical-scientific content of promotional and non-promotional material is fair, balanced, and based on appropriate scientific evidence, as well as complies with local regulatory norms and internal compliance rules under guidance and documented approval by Country Medical Director or Line Manager
  • Ensure compliance of all responsible activities to relevant laws and regulations as well as internal standards and SOPs  under guidance  of Country Medical Director and/or line manager

EXTERNAL STAKEHOLDER MANAGEMENT

  • Establish ongoing relationships with key opinion leaders (KOLs) and healthcare organisations to ensure that significant developments in the field are identified and monitored
  • Establish Takeda’s presence with KOLs and academic institutions in defined geographies for Therapeutic Areas of strategic interest to the company as needed
  • Address unsolicited inquiries from HCPs as needed
  • Disseminate medical insights and intelligence gathered from scientific exchange with KOLs to key internal stakeholders to guide medical and commercial strategies

CROSS-FUNCTIONAL COLLABORATION

  • Provide medical and scientific input in the relevant Therapeutic Area (s) to cross-functional stakeholders, including marketing, regulatory, market access / alliance functions and others as required
  • Provide medical and scientific training to internal stakeholders as needed
  • Support Regulatory Affairs team in assisting with wording and amending labeling information and CMIs (Consumer Medicine Information) under guidance and documented endorsement by Country Medical Director or Line Manager

CLINICAL RESEARCH

  • Provide medical review of all relevant study-related documentation (e.g. informed consents, Clinical Study Reports) either directly under guidance and alignment with  Country Medical Director and/or line manager or through qualified medical staff
  • Support execution of ongoing/future Company Sponsored Studies; provides LOC review of proposed CRO site lists, attends Global/Regional Investigator Meetings if possible, attends site visits, and provides site/investigator feedback to clinical operations when required  
  • Facilitate unsolicited requests from HCPs for investigator-initiated sponsored research (IISR)proposals through engagement with Therapy Lead/Head and Global External Research on IISR proposals and on Medical Affairs Company Studies (MACS)  under guidance and documented endorsement by Country Medical Director and Line Manager
  • Facilitate clinical research data publications and management of publications related to the Therapeutic Area(s)

PATIENT-CENTRICITY

  • Support the Medical Director in planning and implementing patient access programs as needed and as per local regulatory requirements for products within Therapeutic Area (s)
  • Supports reporting and review of adverse events locally and contributes to global pharmacovigilance activities as needed
  • Manages product-related medical safety issues by reporting  incidents to the local PV-team

STRUCTURAL ORGANISATION

  • May be responsible for budget planning, resource allocation and preparation of monthly / quarterly reports for relevant Therapeutic Area(s)

EDUCATION, EXPERIENCE, AND SKILLS

Education

  • Required - Doctoral Degree in Life Science (e.g. Ph.D.), PharmD, Ph.D. or similar  discipline, or medical graduates
  • Preferred - Medical post-graduate (e.g. MD) or equivalent

Experience

  • Required - 3-5 years of prior Medical Affairs and / or Clinical Affairs experience in the pharmaceutical industry
  • Preferred Experience - Product launch experience; Experience working in relevant Therapeutic Area; Experience conducting Advisory Boards; Scientific publications in the Therapeutic Area

TRAVEL REQUIREMENTS

  • Ability to drive to or fly to various meetings/client sites
  • Overnight travel (up to 40%), including weekend commitments
  • Travel may vary depending on geography

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.

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