Associate Scientific Director, Clinical Science is responsible for the strategic leadership and scientific direction for the clinical development 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 GCDT 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. 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 Development Working Groups and ensures alignment with the global strategy.
May act as Global Development Team Leader managing both the Takeda developed or licensed compounds.
Executes and implements the regional team 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 GCDT on disease state, study design, and scientific rationale in clinical studies for compounds within therapeutic area
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, proactive identification of challenges, and development of contingency plans to meet them.
Recommends high impact regional 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 compounds.
Generates and reviews clinical regulatory documents: 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
Leads several Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as a scientific 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
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 GCDT in written, oral and face to face interactions with FDA and EU regulatory agencies, providing clinical expertise within 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.
Due Diligence, Business Development and Alliance Projects
Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing both scientific and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams. For ongoing alliance projects, will 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 with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds.
Active member of various Takeda committees and task forces which define the processes for developing and implementing Global Takeda standards that are used in clinical development, post-marketing surveillance, and Pharmacovigilance process in order to promote the consistency of data throughout the Takeda group companies.
Represents clinical science and leads internal task forces as well as global cross-functional teams as appropriate.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelors required with 15 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) and professional license
Masters in Sciences preferred with 13 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).
PharmD preferred with 12 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).
PhD in a related scientific discipline preferred with 10 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 with responsibility for multiple studies. Global experience preferred.
NDA/MAA/Submission experience 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
Diplomacy and positive influencing abilities
Therapeutic area expertise knowledge relevant to disease states and mechanism of action.