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14 days old

Senior Clinical Research Scientist, Cell and Gene Therapy Biotech

Kelly Services
Cambridge, MA 02238
**Senior Clinical Scientist**


**Cambridge, MA**


**Remote through duration of pandemic, on-site post-pandemic**


**Job Description:**


Worldwide biotech develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.


The Senior Clinical Scientist will lead and/or participate in meetings, reviews, discussions and other interactions regarding early development of Phase I and Phase II pivotal studies to provide clinical science input and guidance to the team.


You will develop the Biomedicine Global Clinical Development plan in collaboration with the Clinical Development Physician for assigned indications, summarize clinical efficacy and safety data, support preparation of Clinical Study Reports, and clinical sections of regulatory documents, and in collaboration with Clinical Development Physicians/Medical Director, you will develop innovative clinical study designs.


**Additional responsibilities include, but are not limited to the following:**


+ Review/draft protocols and provide Clinical Development input into the early development of Phase I and Phase II pivotal studies

+ Prepare targeted reviews/profiles of outliers, search and summarize information relevant for various clinical documents preparation

+ Review and/or write additional clinical science documentation and/or clinical science input into other documentation managed by Biomedicine e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.

+ Gather, analyze and summarize data and information necessary to create the Clinical Development plan Review scientific and medical literature to address clinical needs/assets disease background, conduct literature searches and reference compilation

+ Lead the response generation or assists Clinical Development team in responding to clinical/clinical site inquiries

+ Stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area s Maintain scientific and clinical knowledge in the specific therapeutic and disease areas of assignment and participate in competitive intelligence assessments

+ Represent Clinical Development in sub-teams relevant to assigned therapies/indications. As needed and appropriate, address Clinical Development study or other program-specific questions; provide updates; deliver presentations; etc.

+ May act as the lead Clinical Development representative on sub-teams

+ May also, as appropriate, lead relevant sub-teams in assigning and training new team members with or without direct reporting responsibility

+ Support the completion and submission of regulatory filings and other regulatory documentation Deliver key presentations, both internally and externally, to convey the Clinical Development perspective and provide updates on strategies, plans and other activities.

+ Includes presenting at advisory boards and other relevant external forums representing the company Collaborate with clinical operations, other groups and Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form ICF, protocol eligibility, protocol dose modification, protocol safety, Case Report Forms CRFs , CRF instructions, etc.

+ As needed/appropriate, collaborate with others in the review of safety narratives and other safety-related guidelines and participate in safety meetings and track, analyze and report any potential safe


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-06-04 Expires: 2021-07-05

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Senior Clinical Research Scientist, Cell and Gene Therapy Biotech

Kelly Services
Cambridge, MA 02238

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