Senior Scientific Director, Cell Therapy/Redirected Immunity, Oncology Clinical Science
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Senior Scientific Director, Cell Therapy/Redirected Immunity, Oncology Clinical ScienceApply Now
- The Scientific Director, Cell Therapy/Redirected Immunity, Oncology Clinical Science provides the strategic leadership and scientific direction to ensure that clinical development programs are appropriately designed to support Asset Strategy and OTAU objectives for assigned Takeda pipeline compound(s). Directs a multi-disciplinary, multi-regional, matrix team through highly complex decisions.
- 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 compound in multiple regions.
- This individual interacts with and influences Study Execution Team and Clinical Subteam leadership decision-making by suggesting strategic direction and providing expert therapeutic area and clinical development input. Provides clinical expertise and interacts with regulatory agencies such as the FDA and EMEA, and supports interactions elsewhere.
- Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.
Clinical Development team participation and leadership
- Leads Study Execution Team(s) and/or Clinical Subteam(s) and ensures alignment with the global Asset Strategy.
- Executes the Asset Strategy producing the Clinical Development Plan and Clinical Protocols. Recommends scope, complexity, and size of a program which impacts multimillion dollar budget decisions.
- Provides scientific expertise to functional area representatives in SET/CST on disease state, study design, and scientific rationale in clinical studies for cell therapy/redirected immunity portfolio
- Provides on-going 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, proactively identifying challenges, and developing contingency plans to meet them.
- Recommends high impact decisions. Responsible for monitoring and interpreting data from ongoing internal and external studies. Assesses the scientific implications and makes 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, budget or product labeling.
- Ensures quality of Regulatory Affairs clinical submissions, manages Clinical Development issues, and helps to develop interface between R&D and other functional areas. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
- Authors/supports publication and presentation of clinical and nonclinical data in support of Takeda developed or licensed cell therapy/redirected immunity compounds.
- Generates and reviews clinical regulatory documents in area of scope: Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures, Investigational Product Labeling, IND annual reports, Investigational Medicinal Product Dossiers (IMPD), common technical documents as the basis for new drug applications (NDA) and Marketing Authorization Applications, other EMEA/CHMP regulatory documents and scientific white papers.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans).
- Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings).
- Responsible for review of study data, interpretation of results and communication of study conclusions within the company.
Trial Medical Monitoring
- Integrates necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
- Has significant input on the final decisions regarding study conduct related to scientific integrity.
- Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
- Establishes, maintains and directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with 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.
- May represents SET/CST/GPT in written, oral and face to face interactions with FDA and EU regulatory agencies, providing clinical expertise related to cell therapy/redirected immunity within oncology therapeutic area
- Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
- Collaboratively interacts with scientists from alliance partners.
Leadership, Task Force Participation, Upper Management Accountability
Interacts directly with Oncology Drug Discovery Unit and Oncology Business Unit based on pertinent clinical and development expertise and to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned cell therapy compounds. Represent clinical science on internal task forces. Leads internal teams as appropriate.
- Has leading edge knowledge of principles, concepts, and theories in the discipline. May represent Company or act as an external technical resource.
- Has relevant experience in the field of cell therapy and/or redirected immunity
- Applies technical, line and business knowledge to lead the strategic direction of line and/or zone portfolio.
- Develops innovative ideas and leads complex discipline, department and/or line projects.
- Demonstrates strategic enterprise thinking, finding innovative ways to serve patients, and build trust, reputation and business
- Creates the environment that inspires and enables people to collaborate and move the organization forward
- Focuses on the few priorities and delivers superior results
- Elevates the capabilities of the organization for now and the future
- Decisions have a long-term effect on the objectives of the Oncology TAU and on the Clinical Science function within Takeda R&D
- Decisions impact the Clinical Science discipline and the Oncology TAU
- Exercises foresight and judgment in initiating, planning, organizing and guiding highly complex projects across the clinical development lines.
- Responsible for uncovering and resolving issues associated with the strategic development and implementation of operational programs. Advises colleagues on technical and policy issues; is considered a subject -matter expert providing technical guidance.
- Contribution is evaluated based on business impact requiring a long-term perspective. Reviews work completed by other colleagues outside of direct line and/or from other teams.
- Decisions have a long-term effect on the objectives of the discipline, department and/or line.
- Decisions impact the discipline, department and/or line and its customers.
- Influences the direction of the discipline to Company's advantage. Is a visionary in leveraging an environment of experimentation and developing creative thinking that will have an effect on Company, its partners, and the community.
- Makes decisions by developing innovative options and/or multiple solutions to highly complex problems. Recommends courses of action to management and/or senior leaders that impact the discipline, department or line. Influences the decisions of management/senior leaders.
- Provides/leads in-depth analyses and recommendations to management and senior leaders in complex ambiguous situations across the discipline, department and/or line.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Direct experience with executing development plans with cell therapies and/or redirected immunity approaches
- It is also required that this individual not only have sufficient grounding in the principles of the scientific method, cancer biology and biology of the immune system, but also have experience in oncology drug development and regulatory sciences sufficient to lead internal and external projects relevant to the Oncology TAU across the spectrum of R and D (early and late phase, LCM).
- Bachelor’s, Master’s, PharmD, or PhD degree and 8-10 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
- Additional Job DescriptionAdditional Job Description
Job ID R0020990