Posted to MedZilla on 8/20/2018


Takeda Pharmaceuticals

US-MA, Associate Director Clinical Transparency & Scientific Advocacy R0002321-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director Clinical Transparency & Scientific Advocacy in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Associate Director Clinical Transparency & Scientific Advocacy working on the Global Patient and Scientific Affairs team, you will be empowered to ensure clinical transparency policies at Takeda reflect our core value commitments to integrity and transparency and that all disclosure activities are implemented in full compliance with Takeda policies and applicable requirements. Additionally, you will represent and support Takeda Science Advocacy activities via engagement with non-profit, patient, trade-association and other advocacy partners

At Takeda, clinical trial transparency is considered to support vital scientific and patient-focused core values (of integrity through transparency). This role s main purpose is to proactively and strategically manage Takeda s clinical trial transparency globally to maximize our compliance and commitment to integrity and sustaining Takeda s patient-focused commitment to open research as we develop new medicines. As a senior member of the Science Advocacy team at Takeda, the Associate Director of Clinical Transparency and Scientific Advocacy will not only enhance compliance oversight of transparency activities but will seek to integrate these activities in the context of wider departmental role to support and advance scientific advocacy.

The Associate Director of Clinical Transparency and Scientific Advocacy s:

  • Primary responsibility is to ensure clinical transparency policies at Takeda reflect our core value commitments to integrity and transparency and that all disclosure activities are implemented in full compliance with Takeda policies and applicable requirements. As such this role also has an import regulatory strategy and intelligence aspect to maintain oversight of the evolving external landscape. In addition, this role supports broader patient-centric access to information, academic researcher access to data and facilitates external innovation and partnership through access to information and data.

  • Secondary responsibility will be to represent and support Takeda Science Advocacy activities via engagement with non-profit, patient, trade-association and other advocacy partners as time permits based on primary function. This support for science advocacy and external partnership activities will include both clinical trial transparency and when appropriate non-transparency topics to support selected activities/projects relating to public-private partnerships, patient engagement, and access to medicines initiatives.

ACCOUNTABILITIES

Oversight of Transparency

  • Oversight of Transparency activities under Takeda Policies and Processes: Manages clinical trial transparency activities for all Takeda clinical trials to ensure activities are harmonized worldwide, and comply with all applicable laws, regulations, industry requirements, and Takeda transparency procedures and commitments.
    • Develops, implements and verifies that transparency plans are executed according to milestones and requirements and escalates any at risk or compliance issues to management.
    • Develops oversight plans and project management and compliance tracking methodologies and dashboards for effective work management.
    • Monitors metrics of disclosure activities and evaluates needs to alter process to maximize efficiencies and compliance.
    • Manages the implementation of major clinical trial transparency short to mid-term ad hoc projects including (but not limited to), pilot implementation programs, in-licensing alliance management coordination, transparency transfer for acquisition/divestiture of assets.
  • Manages compliance assessment and as applicable, engages quality assurance, office of ethics and compliance, and external parties/consultants to perform transparency and system compliance audits to verify Takeda policies were followed.
    • Develops routine compliance checks to support constant active management of transparency compliance.
    • Implements in depth compliance oversight leveraging internal/external resources to insure compliance and effectively implement corrective actions
    • Ensures records maintained internally and by vendors are accurate, complete, and retained for proof of regulatory compliance if needed.
    • Develops and maintains any internally required Clinical Trial Transparency records/logs/database of compliance.
  • Provides strategic visibility and implementation leadership to strategically manage change associated with new transparency regulations and requirements at Takeda (eg lay summary capability to support EU CT regulation)
  • Manages vendor(s) budget and contracts to ensure continuity of services and that maximum cost-savings are maximized in parallel with the level/quality of service.
  • Supports internal Takeda transparency communication and participation in internal (eg: cross-functional initiatives) and external industry groups/committees (eg: PhRMA, DIA etc).
  • Supports special digital projects as they relate to TakedaClinicalTrials.com
  • Represents Takeda on external data sharing platforms initiatives and consortia including ClinicalStudyDataRequest.com and Vivli.

Support for Science Advocacy Projects

  • In addition to primary transparency oversight role, Associate Director will participate in select science advocacy projects as time permits. This may include such projects as:
    • Participation in Trade Association (eg PhRMA) workstreams
    • Collaborations with non-profit patient or science advocacy organization (eg to develop white-papers or support meeting sponsorships leveraging engagement with external partners or advocacy groups).
    • Support public-private partnerships through implementation or operational support, especially when relating to transparency initiatives (eg IMI project support).
    • Engagement with expanded access team and patient engagement teams on projects, especially when relating to transparency initiatives (such as individual return of results).

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Bachelor s degree required. Advanced degree preferred
  • Minimum 8 years of experience in the pharmaceutical or health care related industries (e.g. academic research, contract research organization, medical writing).
  • Minimum 6 years of experience with clinical trial transparency, project management or quality assurance.
  • Science advocacy and trade association engagement experience preferable
  • Solid understanding of clinical development, including the phases, processes, and scientific methodology used within a clinical development program from protocol design through regulatory submission.
  • Knowledge of FDA/international regulations and applicable US/international regulatory processes related to good clinical practice and clinical trial disclosure.
  • Ability to effectively develop and implement project or compliance plans.
  • Understanding of how to develop, apply and evaluate effectiveness of policies, procedures, and work instructions to ensure compliance to national, international, and corporate requirements for clinical trial transparency.
  • Ability to manage contract processing and establish budget and invoice oversight procedures to maintain departments targets.
  • Demonstrates problem-solving and interpersonal skills that facilitate effective interactions within global cross-functional teams and vendor(s).
  • Ability to identify issues and generate solutions or request appropriate intervention by management.
  • Ability to effectively manage multiple projects simultaneously.
  • Demonstrates advanced computer software and system skills and online experience (website development/management) is a plus.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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