Shire Clinical Development Scientist in Lexington, Massachusetts
Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of GCDL/GDTL
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 GDTL/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.
Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution (Director)
This position may be combined with the GCDL position when the program is limited in its scope and complexity (Director)
Collaborates with Global Development Team Lead, and Global Clinical 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 GDTL or GCDL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings.
Assist the GDTL/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 GDTL/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/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Education & Experience Requirements
Master’s degree in scientific/healthcare field or nursing qualification is required. Advanced degree i.e. Pharm.D; M.D. or P. hD preferred.
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 II-III clinical trials; and/or
Significant late-stage development research.
Key Skills and Competencies
Expertise in infectious disease and/or ophthalmology 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.
Availability to travel approximately 25% of time.
Availability to participate in early or late meetings/teleconferences.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.