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. The Director 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.
- 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 Pharmacovigilance/QA 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.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Industry Knowledge Comprehensive understanding of pharmacology, the pharmaceutical industry and the prescription drug distribution process in a large healthcare organization or prescription drug vendor.
- Product Knowledge Comprehensive understanding of the medical/therapeutic usage of the products. Expert published medical literature searching and evaluation techniques.
- Takeda Operations Comprehensive understanding of Takeda s operating structure and methods including a thorough knowledge of the foreign-owned parent company.
- FDA Regulations Detailed understanding of FDA regulations and reporting requirements for adverse effects and medical communications.
- Medical Specific health impact of various types of products and potential adverse reactions/drug interactions.
- Research ability to understand and interpret medical research design protocols, advanced statistics and research assessment methodologies
- Communication Ability to translate medical terminology into common vernacular; ability to document/summarize inquiries in a concise/clear format.
- Comprehension Ability to discern patterns in inquiries and reports, and make recommendations to senior management.
- Leadership Ability to train, manage, and motivate a department of advanced degree professionals and other personnel.
Decision-making and Autonomy
- Flexibility and responsiveness Ability to anticipate change and adapt strategies to maintain program integrity and accomplish Takeda s business objectives.
- Resource management Ability to forecast and allocate financial and human resources appropriately.
- Customer Service - Ability to develop solutions that meet/exceed customer needs.
- Relationship building Ability to cultivate a wide network of relationships both internally and externally and promote a team environment.
- Ability to recognize the need and evaluate potential innovative solutions for the identified gaps
- Ability to work with global and US customers/partners
- Ability to cultivate a wide network of relationships both internally and externally and promote a team environment.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- PharmD, PhD, or MD.
- 7+ years relevant experience within Medical Affairs or related industry experience.
- 3-5 years managing people.
- 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.
- 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.
- 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
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