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/Senior Medical Director, Clinical Science in our NS Therapeutic Area Unit 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 / Senior Medical Director leads and drives strategy for the overall global clinical development of assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues. Leads multi-disciplinary, multi-regional, matrix team(s) through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute 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. This individual interacts with and influences R&D senior leadership decision-making by setting 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.
ACCOUNTABILITIES:
Clinical team leadership and Project Team / Clinical team membership
Leads clinical teams as Global Clinical Lead or represents Clinical Science on Project and Clinical teams Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy. Contributes to the overall Asset Strategy by leading generation of the Clinical Development Plan, Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences 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 or supervisor to other medical directors or clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
Trial Medical Monitoring
Responsible for or overseeing 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 and, as applicable, medical directors 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. Leads the development and negotiation of clinical development plans for potential alliances or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during due diligence visits and alliance negotiations and represents clinical science on internal assessment teams. 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 and other functions based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds or disease areas. Represents clinical science and contributes to or leads internal task forces and Therapeutic Area internal teams, including disease area units as well as global cross-functional teams as appropriate. Hires, mentors, motivates, empowers, develops and retains staff to support assigned activities.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education and experience
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 matrix teams. 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
Neurology therapeutic area knowledge desired Regional/global Regulatory requirements GCP/ICH
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 -10 - 20% travel.
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
This job posting excludes CO applicants.
WHAT TAKEDA CAN OFFER YOU:
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
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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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
