The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The Head, Clinical Medicine, PDT R&D will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
- Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and device, and will receive inputs from and into clinical research and manufacturing sciences.
- Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.
The Clinical Director provides strategy for the overall global (US/EU/Japan) clinical development in partnership with Medical Directors and others, taking into consideration the clinical, scientific, regulatory and commercial issues for assigned Takeda PDT R&D BU pipeline and inline products. Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the assigned product in multiple regions. Applies scientific decision making to clinical development issues. This individual interacts with and influences PDT R&D leadership decision-making for the projects by providing strategic direction. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.
- Clinical Development team participation and leadership
- Represents Clinical Development for a given product and/or indication in applicable teams globally (US/EU/Japan) and supports development and execution of medical & clinical strategy in partnership with others to ensure that activities are aligned with the global strategy.
- Responsible for development team strategy and deliverables producing the development strategy, clinical development plan and cinical protocols in close collaboration with other team members. Ongoing work output will involve 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. Provides insight to high impact regional and global decisions. Responsible for interpreting data from ongoing internal and external studies, assessing the 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/or 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, and is accountable for the successful design and interpretation of clinical studies. May present study conclusions to Management and determine how individual study results impact the overall product strategy
- Provides clinical scientist input into all regulatory questions, runs ad hoc searches
- Responsible for targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
- Reviews and interprets data from an overall scientific standpoint
- Provides relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
- Serves as a resource to address clinical questions or clarify issues arising during study conduct
- Participates/contributes/Leads focused cross-functional team meetings within PDT R&D
- Provides support or acts as a company representative interacting with external scientific leaders and/or Regulatory authorities
- Contributes to ongoing monitoring of safety data and regular medical review of clinical trial data.
- Serves as a scientific resource to cross-functional internal teams to support quality of study execution and problem resolution.
- Assures conduction of appropriate steps to support PDT BU and Commercial Teams in crafting target product profiles
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
- Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
- Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
- Participates in drug safety surveillance for Development projects.
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
- Trial Medical Monitoring
- Supports medical monitoring activities, identifying issues related to protocol conduct and/or individual subject safety. Oversees non-medical clinical scientists with respect to assessment of these issues.
- Makes decisions regarding study conduct related to scientific integrity.
- External Interactions
- Directs activities involved in interactions with regulatory authories/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D. Provides leadership and expertise in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
- Leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
- Due Diligence, Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Contributes to scientific and development feasibility by evaluating complete or 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 interfaces with partner to achieve Takeda PDT BU R&D s strategic goals while striving to maintain good working relationship between Takeda PDT BU and partner.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. May represent clinical science on high impact/priority task forces across the organization or external to the company. May lead PDT R&D internal teams and global cross-functional teams, as appropriate.
- May hire, manage, mentor and motivate staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning, as appropriate.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree (Ph.D., M.D. or equivalent)
- Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
- Demonstrated ability to collaborate in a matrixed environment
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities
- Experience in designing and conducting Phase II-III clinical trials
- Significant late-stage development research
- In-depth understanding of drug development within plasma derived-related therapies
- Experince with plasma derived products, particularly, alpha-1 antitrypsin, and/or C1 inhibitor, and/or coagulation factors is preferred.
- Superior communication, strategic, interpersonal and negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Management skills with demonstrated ability to set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to create and maintain an organizational structure that serves the needs of the business.
- Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of PDT BU strategies; demonstrated ability to take a big-picture approach to decision making while taking into account the interests of the entire organization.
- Diplomacy and positive influencing abilities
- Knowledge in Immunology, Immunodeficiencies, Neurology, Pulmonology or related specialties relevant to disease mechanisms and plasma derived/related therapies highly desired
- Working knowledge of regulations relating to drug development
- Emerging research in plasma derived/related therapies
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10 - 20% 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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.