Jobs
>
Boston

    Associate Director/Director, Biomarkers - Boston, United States - PepGen

    Default job background
    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

    • 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 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.



  • PepGen Inc. Boston, United States

    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 ...


  • PepGen Boston, United States

    Job Description · Job DescriptionAssociate 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 ...


  • BioSpace Cambridge, MA, United States

    Job Details · The Role: · Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical sta ...


  • Moderna, Inc. Cambridge, United States

    The Role: · Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs ...


  • Moderna Cambridge, United States

    The Role: · Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID program ...


  • BioSpace, Inc. Cambridge, United States

    Job Details · The Role: · Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical s ...


  • Moderna, Inc. Cambridge, United States Full time

    The Role: · Moderna is seeking a Director of Clinical Biomarkers to serve as a scientific leader and point of contact for clinical teams in the Infectious Disease (ID) space with responsibilities for developing and driving pivotal biomarker plans across clinical stage ID programs ...


  • Moderna Cambridge, United States

    The Role: · The Associate Director of the Biomarker Program Specialist team will be responsible the management of vendors involved in clinical stage program bioanalytical analysis across Moderna's Therapeutic portfolio. The successful candidate will work closely with Program Spec ...


  • Moderna, Inc. Cambridge, United States Full time

    The Role: · The Associate Director of the Biomarker Program Specialist team will be responsible the management of vendors involved in clinical stage program bioanalytical analysis across Modernas Therapeutic portfolio. The successful candidate will work closely with Program Speci ...


  • Massachusetts Housing Partnership Boston, United States

    The Massachusetts Housing Partnership (MHP), a non-profit quasi-public agency, works with communities to create innovative policy and financing solutions that provide affordable homes and better lives for the people of Massachusetts. Our mission is to pioneer new development and ...

  • Project Citizenship

    Associate Director

    1 week ago


    Project Citizenship Boston, United States

    **Key Responsibilities Include**: · - Lead and support a dedicated team of staff and volunteers, fostering a collaborative work culture so that everyone feels welcome, supported, and encouraged to reach their full potential. · - Oversee and manage program operations, ensuring hig ...


  • Bostonian Skilled Nursing Home & Rehabilitation Boston, United States

    The Bostonian Nursing and Rehabilitation Center is seeking a **Full Time Director of Admissions & Marketing** The Bostonian is in a neighorhood setting conveniently located in metro Boston MA, accessible by public transportation. The Bostonian is a preferred, non-profit, post acu ...

  • Joseph Nee South Boston Collaborative Center

    Executive Director

    5 days ago


    Joseph Nee South Boston Collaborative Center Boston, United States

    **Description**: · The Joseph Nee South Boston Collaborative Center is a community-based Non-Profit with a mission to create a safe and welcoming environment providing substance use and mental health counseling services in an outpatient setting serving the Greater Boston Communit ...

  • Pearl Street Collective

    Director of Finance

    1 week ago


    Pearl Street Collective Boston, United States

    America's first trade school, NBSS is a welcoming institution recognized both nationally and internationally for learning excellence. Its spacious, 64,000-square-foot facility is located in Boston's historic North End neighborhood, the community in which it was originally founded ...

  • Office of the Attorney General

    Budget Director

    5 days ago


    Office of the Attorney General Boston, United States

    Budget Director · Executive Bureau · Budget Division · Attorney General Andrea Joy Campbell is seeking a creative, dynamic, and detail-oriented person with budget, finance, and management experience to lead the Attorney General's Office Budget Division. · Primary Duties: The AGO ...

  • Off of Refugees and Immigrants

    Program Director

    6 days ago


    Off of Refugees and Immigrants Boston, United States

    The Office for Refugees and Immigrants (ORI) offers an exhilarating career opportunity for a motivated and experienced Program Director. This role not only supports the work of the Executive Director, the agency's senior staff, and the Program team, but also provides a platform f ...

  • Northeastern University

    Associate Director

    1 week ago


    Northeastern University Boston, United States

    About the Opportunity · **Responsibilities**: · Reporting to the Operations Director - ISEC and EXP, the Associate Director - Lab Operations, responsible for daily management of ISEC and EXP shared labs and core facilities, and supports the Operations Director needs of ISEC and E ...


  • Morgan Lewis Boston, United States

    Morgan, Lewis & Bockius LLP, one of the world's leading global law firms, with offices in strategic hubs of commerce, law, and government across North America, Asia, Europe, and the Middle East, is seeking an Director of Innovation to lead the firm's innovation initiatives, inclu ...

  • New Hampshire Beta Chapter of Sigma Alpha Epsilon

    House Director

    6 days ago


    New Hampshire Beta Chapter of Sigma Alpha Epsilon Boston, United States

    A college Fraternity at the University of New Hampshire has an opening for a live-in Property Manager/House Director. The job requires the applicant to live full-time at the property at nights and on weekends. Directly responsible for managing cleaning staff and cook. · Compensat ...

  • CBS News

    Elc Director

    1 week ago


    CBS News Boston, United States

    WBZ-TV/WSBK-TV/CBSN in Boston, has an immediate opening for a dynamic automated Newscast Director. If you have strong leadership in and out of the control room while fulfilling production needs, we are looking for you to join our team · RESPONSIBILITIES: · - The main responsibili ...