Hemab therapeutics is looking for an Associate Director/ Director / Principal Scientist, Bioanalysis and DMPK

Join Hemab, a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab cultivates a vibrant, agile and forward-thinking environment where collaboration, innovation and high-quality biotherapeutics development go hand in hand.

As an Associate Director/ Director or Principal Scientist, Bioanalysis and DMPK, you will be responsible for planning/ managing and delivering the bioanalytical strategy i.e. pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity assessments for multiple programs in our pipeline with minimal guidance from your manager. You will work directly with external collaborators (CROs and consultants) and with internal cross-functional leads (research, nonclinical, regulatory, quality and clinical development) to help with regulatory filings and clinical study designs. Your role will be essential in expanding the Bioanalytical team's capabilities in-house, offering significant opportunities for professional growth.

At Hemab, we foster an environment where everyone can wear ‘multiple hats’ depending on their experience fit and motivation to get things done ‘right first time’. We constantly strive to celebrate our achievements collectively and gather feedback to continuously sustain and improve our fast-paced cross-functional work environment. 

What you’ll Do at Hemab

• Primarily spearhead and execute the bioanalytical strategy beginning with in vivo pharmacology studies (e.g. proof-of-concept studies) and reaching until at least IND-enabling GLP compliant toxicology studies.
• Contribute as bioanalytical lead for regulatory filings and clinical study design/ execution documents by working cross-functionally between nonclinical, translational, modelling, clinical, regulatory and research teams.
• May also lead or help with clinical bioanalysis deliverables depending on the need, experience fit and motivation for expanding skills.
• Evaluate, select and manage bioanalytical CROs that meet the specific program’s needs and timelines ‘Right first time’. Maintain excellent relationships built on transparent and effective communications with vendors and consultants.
• Keep abreast with current regulatory and industry practices in Bioanalysis for biologics development.
•  Be an open-minded team player and flexible with constructive feedback from other functional leads unique to each program goals and challenges.
• xcellent planning skills combined with a strong scientific mindset.
• Highly organized and analytical with strong problem-solving skills.

Who You Are and What You’ll Bring to Hemab

• Life Sciences Ph.D. plus >4 years or Master’s plus >8 years or Bachelor’s plus >10 years of progressive experience
• Experience from managing bioanalytical or lab operations in biopharma, biotech or a bioanalytical CRO.
• Demonstrated expertise in developing and validating (GLP/ GCLP, ICH) PK, PD Biomarkers and Immunogenicity (ADA, NAb) assays using ligand-based assays (LBA ELISA), Cell-based bioassays, Enzyme-Substrate Activity assays, Mass Spectrometry (LC-MS), PCR-based testing etc…
• Proven skills in bioanalytical data analysis, interpretation, reporting and problem-solving (best-in-class and/ or context of use development).
• Managing CROs as a sponsor or working at a GxP Bioanalytical lab is highly preferred.
• Nonclinical PK and toxicokinetic (TK) assessment and reporting for regulatory filings is highly preferred.
• PK-PD modelling experience is a plus experience with monoclonal antibodies, peptides and nucleic acid therapeutics is preferred.
• Boston, USA or Copenhagen, DENMARK based candidates are preferred but not a must. Intention for this role is to be on-site at either of our offices.