Takeda Pharmaceutical

Clinical Development Scientist III

Posted Oct 28, 2019
Project ID: SHPGJP00004647
Location
Lexington , MA
Duration
1 year (Nov 4, 2019 - Nov 1, 2020)
Hours/week
40 hrs/week
Payrate range
Unknown
The top 3 must haves include:
1. Advanced degree
2. Prior experience in clinical development –
minimum 2 years
3. Good analytical skills and the ability to review
emerging data from clinical studies.

•   Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of GCDL
•   Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
•   Provides clinical scientist input into all regulatory questions, runs ad hoc searches
•   Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
•   Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,
•   Support GCDL to provide scientific leadership in execution of clinical trials
•   Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
•   Serve as a resource to address medical questions or clarify issues arising during conduct of the study
•   Assists Business Development with assessments and intelligence on potential new products and
assists with due diligence activities as required.
•   Assist in the review, analysis and reporting of clinical trial data
•   Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.

•   Collaborates with Global Development Clinical Lead, and Global Product Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and
Consistent.
•   Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
•   Supports the GCDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.
•   Assist the GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
•   Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all
activities.
•   Supports the GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.
•   Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
•   Participates in drug safety surveillance for Development projects.
•   Act on behalf of GCDL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
•   Advanced degree
i.e. Pharm. D/M.D./Ph. D required
•   Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization.
•   Demonstrated ability to collaborate in a matrixed environment
•   Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
•   Experience in designing and conducting Phase 11-111 clinical trials; and/or
•   Significant late-stage development research.

•   Expertise in infectious disease and/or Transplant Medicine preferred
•   Experience in rare diseases highly desired
•   Demonstrated understanding of drug development and pharmaceutical marketing within Therapeutic area.
•   Working knowledge of regulations relating to drug development and promotional activities
•   Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers.
•   Able to work independently, prioritize and meet project timelines
•   Demonstrated ability to effectively present information to employees at all levels of the organization
•   Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.
•   Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization.
•   Ability to capitalize on business opportunities by developing well thought out strategies and initiatives.

Complexity and Problem Solving
•   Good analytical skills and ability to review emerging data and clinical outputs are required daily in
order to make appropriate decisions and institute measures to ensure quality results and safety. It is expected that incumbent will take initiative and work independently, however, ongoing communication with GCDL is a vital part of problem-solving and decision-making.
Incumbent is to escalate any issues requiring GCDL oversight and input.
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