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1+ months

Associate Director, Translational Biomarkers

Kelly Services
South San Francisco, CA 94080
**Kelly Science and Clinical** is the worlds most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.


**Overview**


We are seeking an accomplished biomarker scientist for one of our clients, a start-up biotechnology company dedicated to the research and development of novel therapeutics for the treatment of inflammatory diseases due to vascular dysfunction, in South San Francisco. The incumbent will drive their efforts in the discovery, development, and implementation of novel translational biomarkers in neuroinflammatory and peripheral inflammatory diseases with a focus on neurodegeneration, nephrology and ophthalmology indications. The opportunity is for a scientific leader with extensive experience with translational and clinical biomarkers to support clinical development. The successful candidate will lead the effort in building the biomarker program, driving the strategic and tactical success of biomarker deliverables including target engagement, pharmacodynamic and predictive markers and assays in collaboration with internal and external collaborators.


**Responsibilities**


+ Responsible for designing and implementing biomarker strategies for the clinical pipeline with a focus on assets in late preclinical development transitioning to FIH studies.

+ Deliver timely and high-quality biomarker plans that are fit for purpose to the research leadership team.

+ Play critical role in the development of novel assays and generate robust data to support transfer of assays to CROs for bioanalytical qualification for clinical studies.

+ Establish and lead cross functional biomarker teams providing expertise, driving decisions as well as enabling execution

+ Work closely with the clinical and regulatory teams in generating biomarker analysis plans, tracking sample disposition, tracking data transfers and QC of final data reporting to ensure performance in accordance with study protocols and regulatory needs.

+ Driven, motivated and demonstrated ability to manage and mitigate timeline risks in clinical biomarker efforts.

+ Ensure that they are the biomarker subject matter expert with respect to academic, novel technology, and consortia developments that support our clinical biomarker efforts.

+ Experience in statistical analysis methods to drive utility of multimodal biomarker endpoints would be a plus.

+ Present results, finalize scientific reports as required and help draft biomarker sections for clinical studies and regulatory submission (i.e. clinical protocols, IB, IND, and clinical study reports).

+ Author and present biomarker strategies at project teams, review forums, board meetings and to external groups

+ Perform other related duties as requested


**Qualifications**


+ PhD, PharmD or MD in a relevant scientific field such as nephrology, ophthalmology, neuroscience, inflammation or immunology

+ 5+ years of experience in clinical biomarkers in a biotech or pharmaceutical company setting is required

+ Strong background in translational research in preclinical and clinical settings, drug development and leading teams desired

+ Expertise in the development, execution and oversight of biomarker discovery, development, analysis, and data interpretation with an ability to integrate scientific and disease specific contexts for assets in clinical development

+ Experience developing and outsourcing biomarker assays across a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry) and their clinical application

+ Strong verbal/written communication skills and leadership skills needed to build relationships with key stakeholders in research and development


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-04-22 Expires: 2022-07-23

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Associate Director, Translational Biomarkers

Kelly Services
South San Francisco, CA 94080

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