Associate Director, Translational Biomarkers
Posted 8 hours 37 minutes ago by Meridabio
At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.
Merida Biosciences is seeking a hands on and scientifically rigorous Associate Director of Translational Biomarkers to join our Translational Research team, reporting to the VP of Translational Research. In this role, you will bridge the gap between discovery research and clinical development by taking ownership of biomarker assay development and implementation in clinical studies. You will work closely with the Research team to optimize and characterize complex assays for robustness before transferring them to external partners. You will oversee their qualification or fit for purpose validation and oversee the lifecycle of these assays to support our clinical trials in antibody driven diseases. This is a hybrid role requiring a willingness to work in the lab to ensure assay readiness, combined with the operational acumen to manage external partners and deliver high quality data.
Key Responsibilities- Proactively and collaboratively design and refine biomarker strategies to interrogate mechanism of action and create value from Merida clinical studies.
- Working hands on and closely with the Research team, develop and optimize innovative exploratory biomarker assays for clinical readiness, ensuring they are optimized for robustness and reproducibility prior to transfer. These assays may be based on flow cytometry, ELISPOT, MSD, or other platforms.
- Identify, select, and manage external CROs and specialty labs for clinical biomarker testing.
- Oversee the transfer and qualification and/or validation of biomarker assays at CROs, ensuring alignment with regulatory expectations and clinical timelines.
- Monitor ongoing assay performance and data quality during clinical trials, providing real time interpretation and troubleshooting.
- Partner with Clinical and Clinical Operations to help define sample collection logistics to support generation of quality data.
- Contribute to technical content for biomarker related sections of clinical study protocols, laboratory manuals, and regulatory documents (e.g., INDs, IBs).
- Analyze, interpret, and communicate complex biomarker data to support internal decision making.
- PhD in Immunology, Cell Biology, Pharmacology, or a related discipline with 6+ years of relevant industry experience, OR MS/BS with 8+ years of experience.
- Extensive hands on experience developing and optimizing Flow Cytometry, ELISPOT, and/or multiplexed ligand binding assays (e.g., MSD, Luminex).
- Proven experience with tech transferring assays to CROs and managing external vendors for validation and clinical sample analysis.
- Experience working in a clinical stage biotech environment, with a strong understanding of "fit for purpose" biomarker validation principles.
- Strong understanding of cellular immunology and cytokine biology, particularly in the context of autoimmune or antibody driven diseases.
- Ability to work successfully in a fast paced, matrixed team environment with competing priorities.
- Excellent problem solving skills with the ability to "follow up and follow through" to connect technical problems with operational solutions.
- Strong verbal and written communication skills, with the ability to summarize complex data for cross functional teams.
Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the Associate Director level we target $200,000 to $240,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally.
Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.