- The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds; applies clinical/medical decision making to clinical development issues
- Leads a multi-disciplinary, multi-regional, matrix team through complex decisions. This individual has responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions.
- Reports directly to the Head of Clinical Sciences, Rare Genetic and Immunologic Disorders and Neonatology with matrix reporting to the VP/Global Program Lead Immunology.
- This individual interacts with and influences Takeda Global R&D and Takeda Pharmaceutical Company senior leadership decision-making by setting strategic direction for assigned projects. Success or failure directly translates to the ability of Global R&D to meet its corporate goals and for Takeda to have future commercial products.
- Clinical Development team participation and leadership
- Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represent Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.
- Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influences the budget for all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product.
- Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Trial Medical Monitoring
- Responsible for medical monitoring activities, assessing issues related to protocol conduct and individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes final decisions regarding study conduct related to scientific integrity.
- External Interactions
- Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
- Due Diligence, Business Development and Alliance Projects
- Responsible for identification and evaluation of potential business development opportunities, conducting due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete and ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda s strategic goals while striving to maintain good working relationship between Takeda and partner.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and with commercial to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions. Leads internal teams and may lead global cross-functional teams, as appropriate.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.
CORE ELEMENTS RELATED TO THIS ROLE:
- The Medical Director should be able to perform the role of Global Clinical Leader and Clinical Subteam Leader with minimal supervision.
- The Medical Director typically manages multiple studies, often for several assets.
- He/she will also contribute to Clinical Group tasks, including optimization initiatives.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- NDA/MAA/Submission experience preferred.
- Management experience.
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams
- Diplomacy and positive influencing abilities
- Therapeutic area knowledge relevant to mechanism of action
- Regional/global regulatory requirements
- Emerging research in designated therapeutic area
ADDITIONAL INFORMATION :
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 15 - 25% travel.
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.