Clinical Scientist - Oncology

3316 Takeda Development Center Americas•Boston, MA

5d•Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Clinical Scientist in our Cambridge 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

Bachelor’s degree and 6 years, master’s degree and 4 years, PharmD degree and 2 years, or PhD and 1 year of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
Superior communication, strategic, interpersonal and negotiating skills
Ability to express oneself clearly and concisely to external partners or within the team.
Ability to proactively predict issues and solve problems
Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
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

Responsibilities

Represents Clinical Science on US/EU Development Teams and may serve as leader of this team.
Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy.
Responsible deliverables producing the Development Strategy, with significant contributions to assign sections of the Clinical Development Plan and Clinical Protocols.
Participates in recommending 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 for those areas assigned.
Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies 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.
Responsible for the creation and securing governance approval of the Synopsis / Protocol Development, Study Execution, & Study Interpretation.
Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols ( e.g. Statistical Analysis Plans and Safety Management Plans) for assigned sections.
Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings ( e.g. Investigator Meetings).
Responsible for review of study data, interpretation of results and communication of study conclusions within the company for assigned sections.
Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety.
Provides preliminary assessments to Medical Monitor for review and approval.
Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
Successfully contributes to interactions with regulatory authorities / agencies and key opinion leaders relevant to assigned compound and participate in meetings with representatives of the regulatory organizations and the identification / contact / maintenance of strong Company relationships with key opinion leaders.
Influences establishment of strategy for the compound, and the development of documents 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 by the Company.
Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate .
Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as Development scientific content matter expert for assigned compounds.
May represent clinical science on internal task forces.
May lead internal teams as appropriate.