- Partner with VP, Therapeutic Area, US Medical and TA Medical Directors to develop and execute the regional medical strategy for franchise/products in alignment with the commercial brand strategy and global product teams.
- Monitor plans that support medical strategy and activities for the therapeutic area medical unit including the budget.
- Works with external advocacy group(s), medical societies, and partnerships at a therapeutic area level multiple programs/products and leads scientific advisory boards for the therapeutic area medical unit.
- Serve as the point for Lead LOC responsibilities which include, developing medical strategies for the region, LCM initiatives, IISR (Gap Analysis), and other research activities, involving relevant LOCs. Represent the products and provide medical insights on behalf of region to other functions as required (PV, RA, QA, GSM).
- Serve as a lead at the center of our interface with our alliance medical affairs teams. Develop working structure and decision-making processes for medical affairs interactions and lead the cross partnership working teams.
- Oversee US Medical Affairs activities such as medical and scientific training, advisory boards, medical conferences and communication of relevant learning across the Takeda organization. Act as a scientific lead for assimilation, dissemination and archival of all content developed for the assigned Therapeutic Areas and Products.
- Leads Internal cross-functional meetings. Represent the therapeutic area medical unit s perspective at high level meetings insures alignment across MA functions for the TA medical unit.
- Drives scientific insight in support of medical strategies and from research, publications. for assigned compounds/therapeutic areas.
- Represent the medical franchise and provide scientific and/or strategic insights on multiple therapeutic area/product teams. Committees may include; strategic Global Program Teams (GPTs), US Brand Teams, Launch Planning Teams, Life Cycle Management teams, research teams, Global Outcomes Research Teams, Global Publication Teams, Alliance Partner Teams, and any other teams designated as the compounds evolve. Serves as the lead on Advisory Boards Global Training meetings and Speaker Training Programs.
- Responsible for co-leading the development of regional strategies and research activities for the region.
- Responsible along with Therapeutic Area medical directors to develop and execute collaborative research projects. Develop protocol and facilitate review, identify appropriate collaborators.
- Responsible for managing and coaching Associate Scientific Director(s) and Scientific Directors, and Scientific Leads / Managers; setting performance and development expectations and assessments.
- Responsible for setting up and leading appropriate working group structure and governance decision making process and overseeing the development of shared operational policies and processes between Takeda and alliance partnership medical affairs teams.
- Responsible for driving regional medical advisory boards for the assigned therapeutic area/products per company and OEC guidelines.
- Accountable for ensuring the broader medical strategic plan is linked to the therapeutic area medical unit strategy and product team adapts into materials (i.e. Cross functional/multichannel medical communication strategy, broad implementation of medical communication strategic plan)
- Continuously surveys and translates scientific findings and market events in the assigned therapeutic area to ensure awareness and alignment among internal Takeda partners on issues of potential impact to Takeda/brand and discusses opportunities and action plans.
- Leads teams in developing and maintaining scientific and therapeutic knowledge management resources in the assigned therapeutic area to support activities aligned with scientific and clinical strategies this includes oversight for relevant training activities.
- Develops and maintains a broad network of mutually supportive relationships with internal Takeda colleagues (including GMA, TDC, Marketing, Managed Care, Sales, and other affiliates) to ensure that MA scientific strategies are integrated with those of Takeda as a whole.
- Provides input to budget and is ultimately accountable to ensure maintenance of assigned therapeutic area / medical unit budgets (includes tracking, misses and risk mitigation, insights based on reports received from ops and finance. Set, allocate, trade offs.
- Leads the development of the integrated US Launch plan in support of the Takeda wide Integrated Launch Plan (ILP) and will serve as the medical affairs point on the Core Launch Team.
- Collaborates with Healthcare Quality & Outcomes team and appropriate commercial colleagues to develop product value proposition for payers/providers. Seeks partnership opportunities with external groups and works with internal colleagues to develop program (i.e. disease management program).
- Develop and maintain relationships externally with Professional Associations, Professional Meetings and International/Regional Conferences, etc. to achieve Takeda s medical/scientific strategic objectives, with internal coordination of activities across regions to optimize Takeda s interactions.
- Oversight for the identification, planning, coordination and execution of US medical conferences including medical information booth presence, symposia and alignment of competitive intelligence and conference reporting and post-meeting communication of relevant emerging data with implications for Takeda.
- Collaborates with Field MA Leaders in the development of a strategy and execution of a US KOL engagement plans.
- Responsible for development of TA and product training plans for new and existing products for use by all US Medical Affairs personnel as needed.
EDUCATION, EXPERIENCE AND SKILLS:
- The position requires and advanced degree (MD, PhD, PharmD) in a medical or science-related specialty, although years of experience in the medical field may be considered in lieu of an advanced degree.
- At least 12 years of healthcare or related experience (clinical practice, research, academic or other) following award of said degree, including 8 years of pharmaceutical industry experience (R&D, medical affairs and/or commercial functions).
- 6 years of combined experience in assigned franchise disease state.
- Possesses superior communication skills, both oral and written, and able to engender trust and respect of peers, subordinates and superiors.
- Strong scientific credentials are required in order to communicate with Key Opinion / Thought Leaders, Medical Affairs, Research and Development, as well as other key internal and external stakeholders.
- Firm understanding of the key phases, processes, and compliance factors and techniques that are involved in both the pre-clinical and clinical aspects of drug development.
- Demonstrated understanding of relevant connections and integration points between Medical Affairs and stakeholders across the Development and Commercial functions.
- Proven track record of matrix, teamwork, leading cross-functional teams, timely decision making and results orientation in meeting objectives.
- Demonstrated ability to articulate and negotiate projects and priorities across functions and/or organizations.
- Demonstrated understanding of legal and regulatory environment of pharmaceutical industry
- Visible leadership, personnel management, and ability to work as a team player.
- Clinical, research, or teaching experience.
- MBA or relevant business degree; project management
- Previous cross functional experience
- Doctoral degree in a health sciences related field such as a PharmD, MD or PhD
- Knowledge of and experience with Medical Affairs processes and tools.
- 25-40 % of domestic and international travel will be required to attend key internal and relevant professional meetings.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.