Jobs
>
Boston

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

    PepGen Inc.
    PepGen Inc. Boston, United States

    2 weeks ago

    Default job background
    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 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

    Associate Director/Director, Biomarkers

    4 weeks ago

    PepGen Boston, United States

    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 d ...

  • PepGen

    Associate Director/Director, Biomarkers

    3 weeks ago

    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 ...

  • Moderna, Inc.

    Director, Clinical Biomarkers

    4 weeks ago

    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 ...

  • BioSpace

    Director, Clinical Biomarkers

    2 weeks ago

    BioSpace 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 sta ...

  • Moderna

    Director, Clinical Biomarkers

    3 weeks ago

    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.

    Director, Clinical Biomarkers

    3 weeks ago

    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.

    Director, Clinical Biomarkers

    2 days ago

    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 ...

  • BlueRock Therapeutics

    Director of Imaging and Biomarkers, Translational Medicine

    2 weeks ago

    BlueRock Therapeutics Cambridge, United States

    Who is BlueRock? · BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generatio ...

  • Moderna Theraputics

    Associate Director, Biomarker Program Specialist

    2 weeks ago

    Moderna Theraputics 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 ...

  • BioSpace

    Associate Director, Biomarker Program Specialist

    2 weeks ago

    BioSpace Cambridge, United States

    Job Details · 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 ...

  • ARIAD

    Associate Director Translational Biomarker Lead

    2 weeks ago

    ARIAD Boston, United States

    **Job Level**: · Senior**Travel**: · Minimal (if any) · Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, w ...

  • ARIAD

    Associate Director Translational Biomarker Lead

    2 weeks ago

    ARIAD Boston, United States

    **Job Level**: · Senior**Travel**: · Minimal (if any) · Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, w ...

  • Moderna, Inc.

    Associate Director, Biomarker Program Specialist

    4 weeks ago

    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 ...

  • Moderna

    Associate Director, Biomarker Program Specialist

    3 weeks ago

    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 ...

  • GSK

    Director, Clinical Biomarkers

    2 days ago

    GSK Waltham, United States

    **Site Name**: USA - Massachusetts - Waltham, Baar Onyx, GSK House, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence · **Posted Date**: Jun 5 2024 · **GSK site preferred locations**:US - Waltham, MA,** **Upper Providence, PA. UK - GSK House, Stevenage. Switze ...

  • Beacon Hill

    Director

    2 weeks ago

    Beacon Hill Boston, United States

    Director to $130K - Excellent Role at a Prestigious University · Our client, a well-known university in the Boston area, is searching for a Director to manage one of their student centers to serve the student body and community In this role, the Director will be responsible for ...

  • BioSpace

    Senior Director, Translational Biomarkers

    4 weeks ago

    BioSpace Waltham, United States

    Job Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern olig ...

  • Dyne Therapeutics, Inc.

    Senior Director, Translational Biomarkers

    4 weeks ago

    Dyne Therapeutics, Inc. Waltham, United States

    Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide thera ...

  • Apex Ventures

    Medical Director

    1 week ago

    Apex Ventures Logan, United States

    There are many reasons to collaborate with European Medical Consulting Adam. In the following section, you will see how you can benefit from our free services and save valuable time: * You will have access to exclusive and unpublished job opportunities * Our relocation service wi ...

  • Citisoft Inc

    Director

    3 weeks ago

    Citisoft Inc Boston, United States

    Job Description · Job DescriptionCitisoft is a global consulting firm dedicated to servicing the investment management industry. Our staff and management bring credibility and hands-on knowledge to every facet of our client relationships, backed by a history of successful partner ...