Translational Clinical Research Scientist - NIH

Kelly Services; Bethesda (MD); Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health, vision, dental plans

Paid leave and federal holidays

401K plan

Transit spending account

Résumé du poste

Kelly Government Solutions seeks a Translational Clinical Research Scientist to work on-site at NIH/NIAID in Bethesda, MD. This long-term contract role involves designing clinical protocols, evaluating biomarkers, and coordinating with multidisciplinary teams to advance vaccine and monoclonal antibody programs.

Qualified candidates hold a Ph.D. in a related field with 3+ years of translational research experience in vaccines, and possess strong regulatory and scientific communication skills.

Qualifications

• Ph.D. in Biological Sciences, Biochemistry, Immunology, or related discipline (master’s degree and relevant experience may also be considered).
• Minimum of three years of laboratory-based translational research focusing on vaccines, monoclonal antibodies, and other investigational products.
• Knowledge of clinical trial design, development, and management.
• Ability to design clinical trial protocols for investigational products and assess regulatory requirements.
• Experience reviewing and summarizing complex data for investigational product development.
• Excellent written and oral communication and technical writing skills for scientific teams.

Responsabilités

• Design and implement clinical protocols for evaluation of vaccine and monoclonal antibody products.
• Evaluate biomarkers to inform trial design and monitor product efficacy and safety.
• Identify gaps in preclinical data and suggest future studies.
• Prepare regulatory documents for IND submissions and annual/safety reports.
• Manage protocol and trial development with multicisciplinary teams.
• Collaborate with cross-functional teams to transition products into clinical trials.
• Act as a scientific liaison between laboratory research and clinical operations.

Connaissances

Translational research

Vaccines

Clinical trial design

Regulatory affairs

Scientific writing

Cross-functional collaboration

Formation

PhD in Biological Sciences, Biochemistry, Immunology, or related discipline

Master’s degree with relevant experience considered

Description du poste

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Translational Clinical Research Scientist to work on-site at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Bethesda, MD.

This is a long-term contract position which offers:

• Competitive compensation and comprehensive benefit package
• Optional health, vision, and dental plans
• Paid leave, paid federal holidays, and 401K plan.
• Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS

(1) Work with Principal Investigators in the designing, development, drafting, and implementation of clinical protocols for evaluation of Vaccine Research Center investigational vaccine and monoclonal antibody products.

(2) Evaluate and validate biomarkers or other translational endpoints to inform clinical trial design and monitor investigational product efficacy and safety.

(3) Identify gaps in preclinical data, make recommendations about future studies, and ensure data collection plans are consistent with applicable regulatory requirements and the protocol objectives.

(4) Design, write and develop documents related to the use of investigational products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, and preparing or editing scientific summaries, presentations and publications.

(5) Prepare and review regulatory documents for IND submissions, annual reports, safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types.

(6) Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff.

(7) Collaborate with cross-functional teams (including laboratory scientists, clinicians, regulatory personnel) to ensure seamless transition of candidate products into clinical trials.

(8) Serve as a scientific liaison between laboratory research and clinical operations; assist with the dissemination of information about vaccine, monoclonal antibody and other clinical trials

(9) Assist with quality management activities by reviewing and developing policies and procedures and providing support to risk assessment and clinical monitoring activities.

KEY REQUIREMENTS

(1) Ph.D. in Biological Sciences, Biochemistry, Immunology, or related discipline; master’s degree and relevant experience may also be considered

(2) Minimum of three (3) years of laboratory-based translational research experience focused on vaccines, monoclonal antibodies, and other investigational products

(3) Demonstrated knowledge of the fundamentals and policies associated with clinical trial design, development, and management

(4) Knowledge of and scientific background to inform the design of human clinical trials protocols for investigational products including analytical skills to identify and resolve potential problems related to clinical research and regulatory activities or protocol requirements

(5) Experience to review, collect, assess, and summarize scientific and other complex data and information related to the development of investigational products as part of the design of clinical trial protocols

(6) Excellent oral and written communication skills, technical writing skills and organizational skills as applied to scientific and clinical teams engaged in the development of new investigational vaccines, monoclonal antibodies or related product types.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly Government Solutions?

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world’s most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It’s just another way we make the job search work for you.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en).

Kelly Services is proud to be an Equal Employment Opportunity and Affortative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.