Medical Director, Clinical Science, GI2 TAU

Position Objectives

The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction.

Position Accountabilities

• Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product.
• Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
• Recommends scope, complexity and size, and influence the budget of all aspects of a program.
• Provides 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.
• Responsible for high impact global decisions: 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.
• Drives clinical science 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 determine 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 activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
• Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.
• Serves as clinical contact point for ongoing alliance projects and 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 and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds.
• Lead TGRD internal teams and may lead global cross-functional teams, as appropriate.
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
• Conducts performance reviews and drive goal setting and development planning.

Education, Behavioral Competencies and Skills

• MD or internationally recognized equivalent plus 5 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/matrix team with responsibility for studies in multiple regions.
• NDA/MAA/Submission experience preferred.
• Management experience
• 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 mechanism of action
• Regional/global Regulatory requirements
• Emerging research in designated therapeutic area