Job Description:

PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinicalclinical 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 vendorsplatforms, 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. ResponsibilitiesDevelop and implement biomarker strategies aligned with the organization's objectives, therapeutic area priorities, and regulatory requirementsIdentify and evaluate potential biomarkers for clinical development programs through literature review, data analysis, and collaboration with internal and external stakeholdersLead 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 candidatesEstablish robust validation plans and execute validation studies to demonstrate the clinical utility, analytical validity, and reproducibility of biomarkersImplement appropriate assays and technologies for biomarker quantificationEnsure compliance with relevant quality standards, regulations (e.g., FDA, EMA), and industry best practices in biomarker research and developmentContribute to the preparation and review of biomarker-related sections of regulatory submissions, including INDs, NDAs, and marketing authorization applicationsRequirementsPh.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 developmenProven track record of successful biomarker discovery, validation, and implementation in pharmaceutical, biotechnology, or diagnostic industryIn-depth knowledge of biomarker science and their application in drug developmentStrong analytical and problem-solving skills, with proficiency in statistical analysis software and bioinformatics toolExcellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams and influence decision-making at various organizational levelsExperience interacting with regulatory agencies and preparing biomarker-related documentation for regulatory submissions is preferredDemonstrated leadership capabilities, including project management, mentorship, and strategic planningHands-on experience with development, qualification and validation of biomarker assays based on ddPCR andor Western blotting techniquesAbout 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.