The Clinical Science Fellow is responsible for the strategic leadership and scientific direction for the overall clinical development for assigned Takeda pipeline compound(s). 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 TGRD and TPC senior leadership decision-making by setting strategic direction and providing expert therapeutic area and clinical development input Provides clinical expertise and interacts with regional (US/EU) regulatory agencies such as the FDA and EMEA. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Critically reviews technical and scientific reports from external sources.
- Resolves complex technical issues and ensures that the highest scientific standards are used in support of clinical development studies.
- Provides scientific expertise to functional area representatives of RDT and GDT on disease state, study design, and scientific rationale in clinical studies for compounds within therapeutic area
- Authors/supports publication and presentation of clinical and nonclinical data in support of Takeda developed or licensed compounds.
- Ensures quality of Regulatory Affairs clinical submissions, manages Clinical Development issues, and helps to develop interface between TGRD and other functional areas.
- 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.
- Collaboratively interacts with scientists from alliance partners.
- Establishes, maintains and directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Participates 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.
- Serves as internal expert on clinical development with high degree of accountability.
- Identifies, develops, recommends and/or negotiates novel (but scientifically sound) solutions to meet critical business needs.
- 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.
- Oversees and monitors clinical development studies, including study design, study conduct and procedures for data analysis, quality control and report preparation. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
- Identifies, develops and communicates/negotiates criticality of new scientific tools for effective and thorough clinical development studies.
- Provides input to go/no go decisions.
- Prepares clinical development summaries for NDA, IND and other regulatory submissions.
- 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.
- Ph.D./PharmD or equiv. experience; MD may substitute for Ph.D. with suitable experience
- At least 12 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design. This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work.
- At least 5 years experience in designing and running clinical trials.
- Must have significant pharmaceutical industry experience.
- Must have scientific and technical expertise as evident by publications, patents, awards/honors and credibility at professional societies. Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiations of business goals with regulatory agencies.
- Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
- Must be familiar with pertinent FDA CFRs, FDA guidances, ICH guidelines, contactors and communication with Eudravigilance global regulatory, European clinical trial directives.
- Experience in filing IND, SNDA, ANDA and/or NDA preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 15-25 % travel.
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