Medical Director, Clinical Science, Inflammation TAU

About the Role

The Medical Director, Clinical Development, will provide medical and scientific leadership for a global development program within the Inflammation Therapeutic Area. The role will contribute to clinical strategy and study execution, including study design, protocol development, medical monitoring and safety oversight, clinical data review and interpretation, and preparation of key clinical and regulatory documents. The Medical Director will work closely with cross-functional partners and provide medical input into interactions with investigators, external experts, and regulatory authorities.

How you will Contribute

• Represents Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams
• Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy
• Contributes to the overall Asset Strategy by supporting the development of the Clinical Development Plan, leads the development of Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences the budget of all aspects of a study
• 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
• Recommends high impact global decisions
• Responsible for 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
• Oversees Clinical Science department 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
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or 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
• 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
• Leads incorporation of advice/recommendations received into the design of clinical studies and programs as appropriate
• Responsible for evaluation of potential business development opportunities, conducts due diligence evaluations assessing scientific, medical, and development feasibility, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans
• 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
• Interacts directly with research division based on pertinent clinical and development expertise
• Represents clinical science on high impact/priority task forces across the organization or external to the company
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities

Education, Experience, Knowledge and Skills

• MD or internationally recognized equivalent plus 2 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned)
• Clinical or industry experience in Nephrology or Immunology preferred
• Previous experience successfully leading matrix teams preferred
• Management 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 knowledge relevant to mechanisms of action of compounds in remit
• Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic area

Travel requirements

• 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