Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine

Takeda•Cambridge, MA

7d•$257,600 - $404,800•Hybrid

About The Position

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Medical Director, Clinical Science Neuroscience, in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

Requirements

MD or internationally recognized equivalent plus 7 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.
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

Nice To Haves

NDA/MAA/Submission experience preferred.
Management experience
Therapeutic area knowledge relevant to mechanism of action
Preferably with expertise in sleep medicine
Regional/global Regulatory requirements
GCP/ICH
Emerging research in designated therapeutic area

Responsibilities

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.
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.
Interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction.
Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product.
May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy.
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.
These responsibilities include leadership roles in meetings with the regulatory organizations or 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.
Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
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.
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.
May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC).
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.