- 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
- 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
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Associate Director/Director, Biomarkers - Boston, United States - PepGen
Description
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
Requirements
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 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.
