Head of Medical

1 month ago

Old Toronto, Canada Takeda Full time
p>Job Description

This individual will provide strategic leadership as well as manage and develop medical team members in the Medical/Scientific Liaisons, Scientific Advisors, Pharmacovigilance, Medical Communications, Evidence Generation, and Regulatory departments in Canada. This role will have a key governance role with a focus on ensuring compliance with relevant laws and regulations, as well as internal standards and SOPs. This individual will contribute to the achievement of business success by putting the patient’s needs and safety into primary focus. This leader will also represent local medical functions in a professional and competent manner towards internal and external stakeholders, ensuring alignment across all departments. This role will represent Medical Affairs on the Canadian Leadership as well as within Takeda at the global and regional levels. It is expected the incumbent will maintain an enterprise mindset while driving medical innovation and elevating the value of Medical Affairs within the organization.

KEY JOB ACCOUNTABILITIESLeadership
  • Leverage strong leadership culture to develop and retain highly qualified employees within the company and establish an environment of medical excellence and patient focus to achieve ambitious objectives.
  • Lead local processes to hire experienced medical employees.
  • Support and oversight of on-boarding, medical and scientific training and knowledge transfer together with regional and global medical affairs for medical employees to ensure adherence to internal standards as well as ongoing skills training on negotiations, presentations and networking.
  • Planning and control of medical department plans, resourcing, and budget.
  • Member of the company’s local Crisis Management Team.
  • Member of the company’s local Canadian Leadership Team, representing Medical & Scientific Affairs and contributing to the overall strategy and leadership of the Canadian entity.Clinical Development
    • Final responsible person for the development of clinical research plan according to gap analysis and in alignment with global and local functions (i.e. li>
    • Responsible for 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 proposals to ensure global strategic alignment and execution in line with the company’s standards.
    • Facilitate and support local GCP audits and inspections and oversee completion of GCP related commitments or CAPAs according to the agreed timelines.
    Medical/Scientific Affairs
    • Ensure local medical activities are scientifically sound, within guidelines/directives and the LOC/Regional/Global compliance standards/SOPs, within budget and of appropriate quality and aligned with business strategy and customer and patient needs.
    • Oversee development of local strategic medical plans in line with product Life Cycle Management plans and execution (including the production of local publications, planning and conduct of local advisory board meetings, etc.).
    • Establish and maintain (in alignment with regional and global medical affairs) strong relationships with Key Opinion Leaders.
    • 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.
    • Provide medical contribution to tender business offers and negotiations.
    • Anticipate or identify changes in the marketplace that may provide scientific, medical, regulatory and/or commercial opportunities for the company.
    • Provide medical contribution to market access, reimbursement applications and negotiations.
    • Support local business development/in-licensing activities with scientific evaluations.
    • Act as medical and scientific expert for the company in external engagements and communications.
    • Responsible for the timely and competent handling of all scientific/medical, pharmacovigilance, and regulatory strategies, aspects related to all marketed and developing company products in accordance with appropriate international and regional guidelines/directives, local law and company standards/SOPs.
    Regulatory Affairs
    • Nominate a local regulatory affairs representative.
    • 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
    • Work with Global Medical Information to appropriately respond to unsolicited medical inquiries.
    Quality Assurance – local oversight of:
    • Support the implementation of global standards and Standard Operating Procedures that are aligned with local requirements.
    • Oversee development and maintenance of GxP related controlled documents in the local quality management system.
    Pharmacovigilance – local oversight of:
    • Ensure robust, consistent and compliant LOC pharmacovigilance alignment with Global PV.
    • Ensure basic pharmacovigilance training of all company employees in Canada and of all external service providers involved in activities, where potential AEs are likely to be reported.
    • Nominate a local drug safety officer and deputy.
    • Facilitate and support local pharmacovigilance audits and inspections and oversee completion of pharmacovigilance related commitments or CAPAs according to the agreed timelines.
    Locations

    Toronto, Canada

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

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