Associate Director, Business Operations DMC Lead

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Provide end to end centralized end user/customer support for specified functional areas within Global Development Organization (GDO) & study teams when engaging an HCP to ensure compliance with Takeda transparency and external reporting requirements.
• Responsible for leading operational, project management and coordination for the Data Monitoring Committee(s) / Internal Review Committee(s) (DMC/IRC) activities. Key point of contact for DMC members and DMC Sub-Team members.
• Deliver educational training on centralized HCP engagement process and participate in the development of training materials/job aids.
• Identify supplier(s) of choice for DMC execution and oversee day to day management of vendor(s).
• Serve as a key point of contact for specified functional areas within GDO for HCP engagements including consulting with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of the function.
• Develop, implement, and maintain DMC/IRC R&D wide communication strategy.
• Partner with Global Clinical Development Operations Process Excellence and Delivery team  to determine key performance indicators and measurement of DMC/IRC performance and provide recommendations for areas for improvement.

ACCOUNTABILITIES:

• Collaborate with DMC/IRC Leads in Clin Sci & / or PSPV to finalize DMC timeline, meeting cadences and meeting formats.
• Coordinate the authoring of the DMC/IRC Charter, by partnering with functional representatives, and review with Takeda DMC Lead and DMC Chairperson to finalize version. 
• Distribute and retrieve disclosure forms and contracts, for HCP engagement.
• Prepare and process contract requests, accruals, transparency reporting and correspondence with Health Care Practitioners for GDO. Request/confirm payments to external members per the contract.
• Ensures project management support of the DMC/IRC and continuously improves DMC/IRC processes and structure leveraging technologies to expedite escalation, decision making, and communication related to DMC/IRC activities.
  • Coordinate initial and subsequent meetings per the charter.
  • Distribute charter and any updates to DMC/IRC, collect signatures, and archive in TMF.
  • Prepare meeting minutes, distribute draft, finalize, and archive.
  • Distribute/ensure receipt of data to all DMC/IRC members prior to meetings; coordinate data receipt as prepared by independent statistician per charter.
  • Close-out all HCP engagement/meetings in relevant Takeda systems; Complete targeted reconciliation of engagement.

• Partner with R&D Compliance to support year-end close-out activities in preparation for transparency reporting deadlines. Participate in regular R&D Compliance monitoring activities including the responses and implementation of action plans (as required).

In addition will serve as a member of the Business Operations Team, giving input to key strategic, portfolio, human capital activities that may include:

• Project management support for GCDO, GDO project/initiatives and change-management activities.
• Supports key initiatives and efficiencies for operational deliverables are aligned with GDO Business Operations strategy
• Foster and maintain an engaging culture and continuously improve Business Operations ways of working.
• Support overall inspection readiness, SOP revisions and process documentation updates, and TMF activities, as needed .

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree Science or business-related field.
• 8 or more years of direct experience in the pharmaceutical industry, or related field required.
• Experience influencing senior-level management, with clinical trial background preferred and key stakeholders is a plus.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
• Demonstrated strong project management capabilities.
• Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels where the incumbent may not have direct authority and operate well in ambiguity, demonstrate influential skills and ability to manage conflict to gain alignment.
• Demonstrated ability to work across functions, regions, and cultures.
• Demonstrated leadership with the ability to inspire, motivate and drive results.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
• Demonstrates leadership presence and confidence across all levels of the organization, including Executive level leaders.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.