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OSI
Boston, MA, United States
Associate Director/Director, Biomarker Position Summary PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline. This person will be a key contributor to the clinical biomarker development an
Job Source: OSIGlaxoSmithKline
Waltham, MA, United States
Site Name: USA - Massachusetts - Waltham, Baar Onyx, GSK HQ, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jun 25 2024 GSK site preferred locations: US - Waltham, MA,Upper Providence, PA. UK – GSK House, Stevenage. Switzerland. On-site presence of 2-3 days per week average is anticipated. Additional
Job Source: GlaxoSmithKlineGSK LLP
Waltham, MA, United States
GSK site preferred locations: US - Waltham, MA,Upper Providence, PA. UK - GSK House, Stevenage. Switzerland. On-site presence of 2-3 days per week average is anticipated. Additional flexible arrangements considered on case by case basis. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilit
Job Source: GSK LLPBirdseye Partners
Waltham, MA, United States
Associate Director (Principal Investigator) – Translational Biomarker (Immunology) We are seeking an experienced translational scientist to lead the design and execution of biomarker strategies supporting our early and late-stage research programs. The candidate will develop translational biomarker approaches that measure target engagement, pharmac
Job Source: Birdseye PartnersVertex Pharmaceuticals
Boston, MA, United States
GCP Biomarker Quality Associate Director page is loaded GCP Biomarker Quality Associate Director Apply locations Boston, MA time type Full time posted on Posted 5 Days Ago job requisition id REQ-21957 Job Description General Summary: The Associate Director, Biomarker Operational Quality will provide biomarker q
Job Source: Vertex PharmaceuticalsBlueRock Therapeutics
Cambridge, MA, United States
It continues to be an exciting time for BlueRock Therapeutics as the company advances cutting edge cellular therapies to positively impact patients’ lives across multiple disease areas. The Associate Director Translational Medicine, will be expected to take on a highly visible role with internal and external stakeholders through the management of b
Job Source: BlueRock TherapeuticsICON Clinical Research
Boston
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collabor
Job Source: ICON Clinical ResearchSanofi
Cambridge, MA, United States
Senior Director, NSCLC Biomarker Marketing Position Title: Senior Director, NSCLC Biomarker Marketing, (CEACAM5 ADC) Position Overview/Key Responsibilities: Reporting to the US Franchise Head, Lung Cancer, this role will manage US commercialization initiatives for a priority development stage targeted therapy asset, with primary indications ta
Job Source: SanofiBoston
Job Description Job Description Associate Director/Director, Biomarkers
Position Summary
PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline. This person will be a key contributor to the clinical biomarker development and will be responsible for the identification of appropriate vendors/platforms, the establishment of assays, and oversight of data generation. They will ensure appropriate data analysis and interpretation to support decision-making for clinical-stage programs. Finally, the individual will serve as a resource for discovery- and translational-stage research scientists involved with the identification of potential biomarkers and formulation of development stage-appropriate biomarker plans.
Responsibilities
Develop and implement biomarker strategies aligned with the organization's objectives, therapeutic area priorities, and regulatory requirements
Identify and evaluate potential biomarkers for clinical development programs through literature review, data analysis, and collaboration with internal and external stakeholders
Lead internal and outsourced development and qualification or validation of biomarker assays for clinical trials, applying experience across relevant methods (e.g. qPCR, digital drop PCR, Western blotting), to develop robust assays, generate and analyze data and provide expert interpretation of the effects of promising drug candidates
Establish robust validation plans and execute validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkers
Implement appropriate assays and technologies for biomarker quantification
Ensure compliance with relevant quality standards, regulations (e.g., FDA, EMA), and industry best practices in biomarker research and development
Contribute to the preparation and review of biomarker-related sections of regulatory submissions, including INDs, NDAs, and marketing authorization applications
Requirements
Ph.D. or equivalent degree in a relevant scientific discipline (e.g., molecular biology, biochemistry, pharmacology) with a minimum of 8 years of experience in biomarker research and developmen
Proven track record of successful biomarker discovery, validation, and implementation in pharmaceutical, biotechnology, or diagnostic industry
In-depth knowledge of biomarker science and their application in drug development
Strong analytical and problem-solving skills, with proficiency in statistical analysis software and bioinformatics tool
Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams and influence decision-making at various organizational levels
Experience interacting with regulatory agencies and preparing biomarker-related documentation for regulatory submissions is preferred
Demonstrated leadership capabilities, including project management, mentorship, and strategic planning
Hands-on experience with development, qualification and validation of biomarker assays based on ddPCR and/or Western blotting techniques
About PepGen
PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
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Email Alert for Associate Director/Director, Biomarkers jobs in Boston
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