Director, Global Medical Information & Review

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Job Description

As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Medical Capabilities, Global Medical Affairs Oncology and work with Pharmacovigilance/QA and Legal teams.

How you will contribute:

• The Director, Global Medical Information & Review will lead a high-performing team responsible for Medical Information & Review activities across a broad portfolio of global oncology marketed and pipeline products within Global Medical Affairs Oncology (GMAO). This is a leadership position within GMAO that will ensure Takeda Oncology’s professional standing and integrity with patients, healthcare professionals and the pharmaceutical industry through high-quality and aligned medical information and communication.

• The leader in this position will be accountable for aligning and integrating process and technology efficiencies for all GMAO Medical Information & Review activities, along with being an agent for change management and a champion for modern medical affairs operations. This leader will develop and prioritize functional processes, plans and overall resource allocation to support the GMAO organization, along with supporting the regions and countries for their oncology Medical Information & Review needs, as appropriate.

• Critical to the success of this leader is relationship management with key stakeholder groups such as pharmacovigilance, therapeutic leads, quality assurance and other functions to support a strategically and operationally effective Global Medical Information & Review department for Takeda Oncology. 

ACCOUNTABILITIES:

• Lead, plan and manage budgets and resources, including outsourced services, for global Medical Information & Review to support shifting needs within the organization.

• Lead, manage, coach and develop global Medical Information & Review team members to ensure high performance in achieving a best-in-class global function. Assess performance against functional goals and metrics.

• Work closely with global Medical Information & Review team members to create functional strategies and goals that are aligned with business objectives.

• Oversee implementation of a global Medical Information system for oncology, in collaboration with other Takeda business units, as appropriate; lead global integration and optimization of Medical Information resources, activities, document delivery, and relevant cross-functional databases, including a Medical Information response repository, to support regional and local personnel.

• Ensure Medical Information & Review product-assigned team members collaborate with the brand Medical Communications Leads to ensure consistency of Medical Information & Review content with the product scientific platform(s)—a foundational document driving one scientific voice when communicating disease and product information.

• Lead needs assessments and development of global core response documents (GCRDs) that are strategically aligned with regional and local needs, and partner with global Medical Leads, as appropriate, to ensure approval of GCRDs.

• Directly oversee and manage the medical information contact center operations on behalf of the US Oncology Medical Affairs organization—actively monitor efficiency and continuously assess technology improvements to maintain operations in-line with best practices and industry standards.

• Partner with global to establish an integrated global approach to appropriate reporting of spontaneous adverse events/product complaints and oversee the development of relevant processes and data channels for information flow.

• Establish a robust approach to intelligent assessment and early detection of patterns in requests for medical information, and lead appropriate and integrated responses to signals that are strategic and business critical for the organization.

• Oversee the team of professionals who provide advanced medical and scientific review of non-promotional medical affairs materials, as well as overseeing the processes, logistics and project management of the medical review process, as needed.

• Determine medical congress booth support and scientific coverage, as needed, considering budgetary and personnel constraints, through collaboration with the global medical strategy team oncology (GMSTO) and the global brand teams (GBT).

• Create regular and accessible reports and dashboards of medical information metrics for senior management, along with compliance monitoring for area of accountability. Identify needs for process improvements in Medical Information & Review.

• Ensure maintenance of relevant SOPs and work practices for oncology in partnership with other stakeholders as appropriate.

• Monitor and communicate Medical Information & Review best practices to the global community. Remain current in related regulations, Takeda policies, and new regulations affecting medical affairs to ensure systems, processes, and procedures accurately reflect current global standards.

• For products with alliance partnerships, lead establishment and alignment of medical information materials and activities, in partnership with relevant stakeholders.

• Coach and mentor interns, and students, as appropriate.

• Critical to the success of this leader is relationship management with key stakeholder groups such as pharmacovigilance, therapeutic leads, quality assurance and other functions to support a strategically and operationally effective Global Medical Information & Review department for Takeda Oncology. 

Basic Requirements/Qualifications

Required:

• Bachelor’s degree in a scientific discipline plus commensurate long-term experience within pharmaceutical or biotech industry

• 7+ years of healthcare or related experience, including 5+ years of medical affairs and/or publications planning and execution experience and including 3+ years of budgetary and/or people management experience

• Excellent written and oral communication skills.

• Significant experience and knowledge of clinical trial reports, data presentation, and interpretation.

• Advanced understanding of challenges and opportunities in Global Medical Information & Review.

• Proficient with Global Medical Information & Review systems, processes and reporting tools.

• Proven track record of leadership, teamwork, timely decision making and focus on results.

• Demonstrated experience with change management and knowledgeable in modern medical affairs operations pertaining to Global Medical Information & Review.

• Proficient with Microsoft Office applications.

Preferred:

• Advanced degree (PhD, PharmD or equivalent) in a scientific discipline preferred

• Therapeutic area experience in oncology.

• Post-doctoral residency or fellowship, or sufficient applicable experience.

• Prior experience leading a global integration of medical information systems and processes.

Travel Requirements:

• Willingness to travel to various meetings or client sites, including overnight trips. Some international or weekend travel may be required.

• Requires approximately 5-30 % travel

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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