The Sr. Medical Director leads and drives strategy for the overall global clinical development of our Norovirus vaccine candidate taking into consideration the medical, safety and scientific, regulatory and commercial issues for assigned Takeda pipeline compounds.
Leads a - multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for clinical development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan for assigned projects that will result in the regulatory approval of the assigned vaccine in multiple regions.
He / She applies clinical / medical decision-making to clinical development issues.
He / She interacts with and influences VBU senior leadership, CSMO leadership and TDC Asia, Success or failure directly translates to the ability of Takeda vaccines to meet its corporate goals and for Takeda to have future commercial products.
Clinical Development team participation and leadership
o Leads Global Development Team managing for a given vaccine. May lead the regional Development Teams and represents Clinical development on the Global Development Team to ensure that activities are aligned with the global strategy.
o Scientific expertise on the clinical development for assigned compounds and takes accountability to the creation of regulatory documents such as Investigational New Drug Applications (INDs), Regulatory Briefing Documents, Investigational Brochures, Investigational Medicinal Product Dossiers (IMPD), Common Technical Documents (CTD) as the basis for New Drug Applications (NDA) in the US and Market Authorization Applications (MAA) in the EU, IND annual reports, EMEA / CHMP documents (other authorities and related documents as applicable), and scientific white papers.
Leads clinical part of interactions with FDA, EU and other regulatory agencies, particularly in the area of clinical development and clinical research, contributes to presentations of clinical data in support of assigned Takeda pipeline compounds, and takes accountability to lead Global Development Team and Medical Writers to assure accuracy of data in regulatory documents.
o Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
Recommends and drives 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.
o 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.
A significant error in judgment may result in loss of approvability and commercial viability of a product.
o Represents clinical development on VBU GPT
Synopsis / Protocol Development, Study Execution & Study Interpretation
o Drives clinical development activities relating to the preparation / approval of synopses, protocols, other relevant documents (e.
g. Investigator Brochure) and the conduct of clinical studies. Serves as an advisor to other clinical development team members 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.
o Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
o 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.
o Makes final decisions regarding study conduct related to scientific integrity.
o 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.
These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the preparation of relevant documents and / or 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.
accountable to senior leadership for the successful completion of related objectives.
Due Diligence, Business Development and Alliance Projects
o 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.
Assesses scientific, medical, and development feasibility,
evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner / acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA / TPEU / TPC.
o 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.
Leadership, Task Force Participation, Upper Management Accountability
o 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 TDC scientific content matter expert for assigned compounds.
May represent clinical science on multidisciplinary task forces across divisions (e.g. TDC and TPNA / TPEU / TPC). Lead TDC internal teams and may lead global cross-functional teams, as appropriate.
o Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.
EDUCATION, EXPERIENCE AND SKILLS :
MD or internationally recognized equivalent desirable, PhD with relevant industry and leadership experience possible
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 aforementioned).
Previous experience successfully leading a clinical development team / matrix team with responsibility for studies in multiple regions.
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 knowledge relevant to mechanism of action
Regional / global Regulatory requirements
GCP / ICH
Emerging research in designated therapeutic area
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.
Job ID R0020906