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

Job Description

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.

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. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.

Accountabilities

• Clinical Development team participation and leadership
• 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.
• 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.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation
• 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 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.
• Trial Medical Monitoring
• 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.
• Makes final decisions regarding study conduct related to scientific integrity.
• External Interactions
• 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.
• Due Diligence, Business Development and Alliance Projects
• 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.
• Leadership, Task Force Participation, Upper Management Accountability
• Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment.
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.

Education, Behavioral Competencies and Skills

• 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.
• NDA/MAA/Submission experience preferred.
• Management experience.

Skills

• 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.

Knowledge

• 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.

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.

Location

USA - MA - Cambridge

Compensation and Benefits Summary

U.S. Base Salary Range: $257,600.00 - $404,800.00

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Employment Type

Employee, Regular, Full time, Exempt.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.