Clinical Scientific Director

Takeda•Cambridge, MA

23h•$177,000 - $278,080•Onsite

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 Scientific Director in our NS Therapeutic Area Unit. 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

Advanced life science degree or internationally recognized equivalent plus 3 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). Alternatively bachelor’s degree and at least 5 years experience.
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
Neurology therapeutic area knowledge desired
Regional/global Regulatory requirements
GCP/ICH

Responsibilities

Represents Clinical Science on Study Execution and Clinical Teams.
Supports the Clinical Subteam to ensure that the clinical team activities are aligned with the global strategy.
Contributes to Global Project and Clinical Subteam 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 influences the budget of aspects of a study or program.
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.
Ensures that at all times the scientific rigor and integrity of clinical trials are maintained, and that the resulting data are of high quality to allow data-driven decision-making.
In this role works with, and leads, other functional representatives to ensure optimal data quality.
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.
Oversees or contributes to Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies.
Serves as an advisor to other clinical science personnel involved in these activities and contributes to the successful design and interpretation of clinical studies.
Interprets data from an overall scientific standpoint as well as within the context of the clinical significance to individual patients.
May present study conclusions to Management and determine how individual study results impact the overall compound strategy.
Responsible for clinical data monitoring activities, assessing issues related to protocol conduct, data quality and integrity, and participant well-being.
Assesses overall safety information for studies and compound in conjunction with the study medical director and Pharmacovigilance.
May oversee other clinical scientists with respect to assessment of these issues.
Informs final decisions regarding study conduct related to scientific integrity.
Contributes to or leads interactions with study investigators, key opinion leaders relevant to assigned studies, compounds and therapeutic area.
Contributes to developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing or summary documents), materials used for meeting presentations, and formal responses to communications received from the regulatory authorities, IRBs/ECs, or opinion leaders.
Leads or contributes to incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
Consulted for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
Contributes to the development of clinical development plans and studies for potential alliances and or in-licensing opportunities and represents clinical science on internal assessment teams.
For ongoing alliance projects, may interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
Interacts with development functions, e.g. Data Science or Clinical Operations, and Drug Discovery Unit and other preclinical 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.
Represents clinical science and contributes to or leads internal task forces and Therapeutic Area internal teams as well as global cross-functional teams as appropriate.