Job Description

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Neuroscience TAU- Stroke Neurologist 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.

POSITION OBJECTIVES:

The Medical Director

• leads and drives strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues.
• Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions. 
• Has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions. 
• Applies clinical/medical decision making to clinical development issues. 
• Interacts with and influences Neuroscience Therapeutic Area Unit senior leadership decision-making by contributing to strategic direction. 
• Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.

POSITION ACCOUNTABILITIES:

Clinical team participation and leadership:

• Represents Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams.
• Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy.
• May act as Global Clinical Lead for an early or a smaller scope product.
• Contributes to Global Project and clinical team strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution. Recommends scope, complexity and size, and influence the budget of all aspects of a study or program. 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.

Synopsis / Protocol Development, Study Execution, & Study Interpretation:

• Oversees all 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.
• Oversees non-medical clinical scientists with respect to assessment of these issues.
• Makes final decisions regarding study conduct related to scientific integrity.

External Interactions:

• 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.

Due Diligence, Business Development and Alliance Projects:

• Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
• Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
• 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.

Leadership, Task Force Participation, Upper Management Accountability:

• Interacts with research division based on pertinent clinical and development expertise and with other functions to provide knowledge / understanding of market environment in line with status Neuroscience TAU scientific content matter expert for assigned compounds.
• Represents clinical science and leads internal task forces and R&D internal teams as well as global cross-functional teams as appropriate.
• 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
• Experience managing stroke strongly desired
• Previous experience successfully leading matrix teams 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
• Knowledge of egional/global Regulatory requirements and GCP/ICH

TRAVEL REQUIREMENTS:

• Ability to drive to or fly to various meetings, conferences, trial sites, regulatory interactions including overnight trips. International travel likely required.
• Requires approximately –10 - 20% travel.

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

Discover more at takedajobs.com

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Cambridge

U.S. Base Salary Range:

$228,200.00 - $358,600.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

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.

Locations

USA - MA - Cambridge

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Tags

Minimum wage, Full time, Temporary work, Work at office, Local area, Night shift,

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