Hemab is a clinical-stage biotech company focused on addressing the high unmet needs of patients with rare bleeding and thrombotic disorders. With offices in Cambridge, MA and Copenhagen, Denmark, Hemab offers a collaborative, agile, and science-driven environment dedicated to developing high-quality biotherapeutics.
Location: Flexible within the U.S. or EU | Remote eligible
POSITION OVERVIEW
The Director/Senior Director of Bioanalytics plays a critical leadership role in developing and executing bioanalytical strategies across Hemab's portfolio, from early discovery through clinical development. Reporting to the Quantitative clinical pharmacology (QCP) Lead, this individual will oversee all bioanalytical activities including assay development, method validation, sample analysis, and CRO management to support our innovative biologics programs for bleeding and thrombotic disorders. This role requires strategic thinking combined with strong technical expertise in immunoassay and LC-MS/MS assay development and a proven ability to build and maintain collaborative relationships acros internal teams and external partners. The successful candidate will lead a small team, manage a network of external CROs, and ensure delivery of high-quality bioanalytical data and regulatory documentation to support INDs, BLAs, IBs, and global regulatory submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop and implement comprehensive bioanalytical strategies for monoclonal and bispecific antibody, siRNA and therapeutic peptide programs from discovery through Phase 3 clinical development
- Lead design and execution of bioanalytical assays including PK, ADA, biomarker, and specialized coagulation assays to support nonclinical and clinical studies
- Serve as primary strategic contact for bioanalytical CROs and contract laboratories; evaluate, select, audit, and manage vendor partnerships
- Conduct technical monitoring of method development, validation, and sample analysis at external vendors; oversee data and method transfers between CROs
- Manage bioanalytical budgets, timelines, and quality oversight across multiple vendors and programs; perform regular CRO site visits
- Review and interpret bioanalytical data, validation data and reports, and study reports to ensure scientific rigor and regulatory compliance
- Author or contribute to bioanalytical sections of regulatory documents (INDs, IBs, CTDs, NDAs/BLAs) and represent bioanalytics in regulatory interactions
- Partner closely with cross-functional teams including Research, Nonclinical, Clinical Development, Regulatory Affairs, CMC, and Project Management
- Communicate bioanalytical strategies, results, and timelines clearly to stakeholders; proactively identify and escalate risks impacting timelines or data/regulatory quality
- Manage and mentor direct reports; foster a collaborative, high-performance team culture
Who You Are
- Ph.D. in analytical chemistry, biochemistry, immunology, or related field with 10+ years of relevant industry experience, or M.S. in related field with 15+ years of relevant industry experience
- Minimum 5 years of experience in bioanalytical support for biologics (monoclonal antibodies, bispecifics, or similar modalities)
- Deep expertise in immunoassay technologies (ELISA, MSD, Luminex, flow cytometry) and LC-MS/MS for large molecule bioanalysis
- Strong knowledge of PK,ADA, and biomarker assay development, validation, and regulatory expectations
- Hands-on experience in assay development and troubleshooting (not purely strategic oversight)
- Proven track record managing bioanalytical CROs and contract laboratories
- Experience supporting regulatory submissions (IND, IB, NDA/BLA) with high-quality bioanalytical data and documentation
- Understanding of GLP/GCP regulations and bioanalytical method validation guidelines (FDA, EMA, ICH)
- Excellent communication skills with ability to translate complex scientific concepts for diverse audiences
- Demonstrated ability to build and maintain strong working relationships across functions and with external partners
- Collaborative mindset with commitment to team success, transparency, and high integrity
- Demonstrated ability to lead and mentor a team of dedicated bioanalytical scientists
- Thrive in a dynamic, fast-paced biotech environment with shifting priorities
Preferred Qualifications
- Experience with hemostasis or coagulation assays (thrombin generation, clotting factor activity assays, etc.)
- Regulatory writing experience (authored bioanalytical sections of INDs, IBs, or CTDs)• Demonstrated experience with developing and evolving an immunogenicity testing strategy throughout clinical development, including leading immunogenicity risk assessments
- Engaged with the bioanalysis and immunogenicity communities and knowledgeable of emerging industry trends
- Experience in rare disease or hematology therapeutic areas
- Prior experience in early-stage biotech companies with lean teams and evolving priorities
Why This Role Stands Out
- Strategic leadership role with direct impact on program advancement
- Opportunity to build and shape bioanalytical capabilities in a rare disease biotech
- Lead a team while maintaining technical engagement across discovery and clinical programs
- Flexible, remote-friendly U.S. or EU role
