Associate Director, Clinical Biomarker Lead

2 hours ago

Cambridge, Massachusetts, United States BioSpace, Inc. Full time
Job Title: Associate Director, Clinical Biomarker

We are seeking a highly skilled Associate Director, Clinical Biomarker to join our team at BioSpace, Inc. This role will be responsible for developing and driving biomarker plans across clinical stage Infectious Disease programs.

About the Role:
  • Evaluate technologies to identify, define, and implement the biomarker strategy to support the clinical development of our vaccines.
  • Develop biomarker plans with input from research and clinical leads.
  • Manage biomarker assay labs to complete appropriate development, qualification, or validation studies to execute the clinical biomarker plan on time and with good quality.
  • Ensure the timely and efficient delivery of all biomarker operational aspects across vaccine clinical trials, accountable for planning, coordinating, and overseeing all operational activities required to manage the flow of biomarker samples from planning, collection, analysis, data delivery, and final sample disposition with support from the Biosample Operations Manager.
  • Develop and provide operational input and recommendations into all study-related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery, and analysis of biosamples in compliance with these documents as well as GCP/ICH.
  • Serve as a single point of contact for biomarker operations across vaccine teams and with collaborators, assay labs, and CROs.
  • Responsible for the identification and selection of biomarker vendors in collaboration with the Translational Science/Research leads.
  • Manage the development and oversight of the biomarker analysis timelines, budget, risk, and quality plans.
  • Attend operations team meetings and monitor training, CRO kick-off meetings, as applicable, to deliver trainings on biomarker activities.
  • Participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data transfer and collection.
About You:
  • MS (with at least 8 years pharmaceutical/biotechnology experience) or PhD (with at least 2-4 years of pharmaceutical or biotechnology experience) in a related science focus (i.e., immunology, molecular biology, biotechnology).
  • Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure.
  • Experience in Infectious disease programs (Ex: Human respiratory viruses / Human herpes viruses / HIV / Human Flaviviruses / Bacterial diseases) is highly desirable.
  • Diagnostic assay development and testing experience is desirable.
  • Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research, validation, and implementation.
  • Experience in managing third-party assay laboratories, collaborations, and budget management.
  • Strong communication and project management skills.
About Us:

BioSpace, Inc. is a leading biotechnology company dedicated to developing innovative mRNA technology platforms. We are committed to creating a culture of belonging and building an organization that cares deeply for our patients, employees, the environment, and our communities.

We offer a comprehensive and innovative suite of benefits, including:

  • Highly competitive and inclusive medical, dental, and vision coverage options.
  • Flexible Spending Accounts for medical expenses and dependent care expenses.
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities.
  • Family care benefits, including subsidized back-up care options and on-demand tutoring.
  • Free premium access to fitness, nutrition, and mindfulness classes.
  • Exclusive preferred pricing on Peloton fitness equipment.
  • Adoption and family-planning benefits.
  • Dedicated care coordination support for our LGBTQ+ community.
  • Generous paid time off, including vacation, sick time, and holidays.
  • Volunteer time to participate within your community.
  • Discretionary year-end shutdown.
  • Paid sabbatical after 5 years; every 3 years thereafter.
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents.
  • 401k match and Financial Planning tools.
  • Moderna-paid Life, LTD, and STD insurance coverages, as well as voluntary benefit options.
  • Complimentary concierge service including home services research, travel booking, and entertainment requests.
  • Free parking or subsidized commuter passes.
  • Location-specific perks and extras.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

We are an E-Verify Employer in the United States and consider qualified applicants regardless of criminal histories, consistent with legal requirements.

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