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Head of Medical Affairs

応募 後で応募 求人ID R0008342 掲載日 05/21/2019 Location:Brussels, Belgium

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Job Description

ROLE OBJECTIVE

  • Provide strategic leadership of Medical personnel; manage and develop Medical personnel to achieve optimal performance
  • Contribute to the achievement of business success by putting the patient’s needs and safety into primary focus
  • Ensure compliance of LOC / MCO to the code of conduct, corporate philosophy, relevant laws and regulations as well as SOPs and policies
  • Represent local medical functions in a professional and competent manner towards internal and external stakeholders; ensure alignment, collaboration and proactive sharing of relevant information across all departments

Lead overall company vision and direction for the portfolio at LOC level

ACCOUNTABILITIES

Leadership

  • Provide direction and input into the overall strategic roadmap of the LOC incl. building of required capabilities for the futures
  • Ensure medical plans are aligned cross-functionally and aligned with the company’s strategy as well as delivered on time and on budget
  • Leverage strong leadership to develop and bind highly qualified employees to the company and to offer stimuli for reaching ambitious objectives
  • Support on-boarding, training and knowledge transfer within the medical department providing an upskilling on areas of improvement as agreed within the leadership team
  • Ambassador for Corporate Philosophy and Takeda-ism
  • Lead local processes to hire new medical personnel

Medical/Scientific Affairs1

  • Responsible for adherence to Global / EUCAN Compliance Standards for the Non-Commercial (Scientific) processes
  • Guarantee scientific accuracy and adherence to ethical and industry standards regarding medical information, medical staff and sales force training, promotion of products marketed in accordance with the local Drug Law and Takeda’s standards / SOPs
  • Oversee development of local tactical medical plans in line with the BU strategy and execution (including the production of local publications, planning and conduct of local Advisory Board meetings etc.)
  • Liaise with other Department Heads (BU, PVA) to ensure common understanding of customer needs and alignment on applied strategy
  • Establish and maintain –in alignment with Regional and Global Medical Affairs- strong relationships with Key Opinion Leaders (KOLs) as well as establish network including medical, clinical and academic community, authorities, pharma industry, payers and other relevant stakeholders
  • Establish and develop Medical Liaison Managers in the country including territory alignment, targeting and segmentation
  • Develop HCP mapping and segmentation principles as basis of MSL territory alignment in coordination with commercial excellence where applicable; set standards for local/regional HCP mapping by MSLs
  • Provide medical contribution to Tender Business offers and negotiations; support local Business Development/In-licensing activities with scientific evaluations
  • Anticipate or identify changes in the marketplace that may provide scientific, medical, regulatory and/or commercial opportunities for Takeda
  • Provide medical contribution to market access, reimbursement applications and negotiations
  • Act as media Spokesperson on medical topics, therefore act as Takeda representative in front of competent authorities for subjects under his/her responsibility
  • Act as communication link between local Departments and Regional and global medical functions
  • Supervise Medical Education, Publications, Insight Generation activities
  • Responsible for the timely and competent handling of all scientific/medical aspects related to all marketed and developing Takeda products in accordance with appropriate international and regional Guidelines/Directives, local law and Takeda standards/SOPs
  • Develop and oversee execution of medical training of LOC / MCO personnel
  • Establish a KPIs system for MSLs and operationalize in CRM
  • Clinical Research

  • Final responsible person for the development of clinical research plan (both interventional and non-interventional, including RWE) according to gap analysis and in alignment with Global and local functions (i.e. Patient Value and Access)
  • Responsible for the scientific integrity, GCP adherence, (global) strategic alignment, safety, design, high quality and timely conduct of local clinical studies
  • Oversee the evaluation and support of local Investigator Initiated Sponsored Research (IISR) proposals to ensure global strategic alignment and execution in line with Takeda standards
  • Facilitate and support local GCP audits and inspections and oversee completion of GCP related commitments or CAPAs according to the agreed time lines.
  • Quality Assurance

  • Support the implementation of Global PDD Standards and Standard Operating procedures (SOPs) that are aligned with local requirements
  • Oversee development and maintenance of GxP related controlled documents in the local Quality Management System
  • Regulatory Affairs

  • Nominate a local Regulatory Affairs Responsible
  • Oversee label creation, review and approval processes in LOC / MCO
  • Support (global products) or oversee (local products) regulatory submissions to local Regulatory Authority
  • Oversee communication with local Regulatory Authority
  • Guarantee accuracy and adherence to local Regulatory Authorities legislation, guidelines and other relevant documents and proactively inform management on relevant changes

  • Medical Information

  • Oversee a tracking system for all unsolicited medical enquiries and a timely, accurate and balanced answering to unsolicited medical enquiries
  • Pharmacovigilance (global function)

  • Ensure robust, consistent and compliant Pharmacovigilance (PV) processes (e.g. 24/7 coverage, business continuity plan, service level agreement, DSO mail box, other safety information including product recall) are in place
  • Ensure basic PV training of all Takeda employees in the country and of all external service providers involved in activities, where potential AEs are likely to be reported
  • Nominate a local Drug Safety Officer (DSO) and deputy (DDSO)
  • Oversee all PV related responsibilities and activities undertaken in the LOC
  • Facilitate and support local PV audits and inspections and oversee completion of PV related commitments or CAPAs according to the agreed time lines
  • Patient Services and Solutions

  • Develops and implements best-in -class patient support programs and solutions aligned with the BU strategies, utilizing best practice processes of analyzing and optimizing the Patient Journey from diagnosis to treatment
  • Works closely with Compliance, Legal, Regulatory when creating services
  • Drives Patient Service excellence and conversion to treatment programs 
  • Creates and delivers a plan with BU Directors to expand patient support programs
  • Management of contracts and development of new service provisions
  • Develops and tracks agreed KPIs associated with patient services

SKILLS and LEADERSHIP CAPABILITIES

Critical Skills and Competencies

  • Compliance insights: Profound understanding of compliance and medical Ethics, ability to navigate complex situations balancing SOPs, regulations, our values and business interests
  • Collaborative leadership: Advanced communication skills to build and shape team and external relationships (with KOLs, policy makers, health economists, scientific societies, etc.)
  • Business acumen coupled with drive for results, holding self and others accountable for commitments that align with our short- and long-term goals
  • Customer centricity: Ability to understand the customers' needs, leading complex collaborations successfully and creating genuine win-win solutions
  • Knowledge of healthcare systems, medical quality assurance, quality improvement, risk management
  • Strong project management skills: ability to manage multiple projects simultaneously

Experience and Education

  • Extensive medical experience, Medical degree
  • Advanced degree in management, such as M.B.A., M.P.H. or M.H.A. is an advantage
  • Min 3 years’ experience working in a team environment and in a supervisory position managing direct reports
  • Min 6 years of experience of pharmaceutical industry experience

Locations

Brussels, Belgium

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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