Director of Clinical Bioanalysis and DMPK

SUMMARY:

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 a Director of Clinical Bioanalysis and DMPK, you will be responsible for planning/ managing and delivering the bioanalysis and pharmacology strategy through execution of pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity assessments, PK-PD modeling and pharmacometrics modules for clinical stage asset(s) in our pipeline. You will work directly with external collaborators (CROs and consultants) and with internal cross-functional leads (clinical development, clinical operations, biometrics, regulatory and quality) to help with clinical study designs/ workflows and regulatory filings. Your role will be essential in expanding the Bioanalysis and DMPK 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 clinical bioanalysis and/ or pharmacology strategy beginning in pre-phase 1/2 and through pivotal studies and approvals.
• Contribute as bioanalytical and/ or pharmacology lead for establishing clinical proof-of-concept (PoC), dosing recommendations, clinical study design/ execution documents and regulatory filings by working cross-functionally primarily with clinical development, clinical operations regulatory and quality teams.
• Lead PK-PD modeling and pharmacometrics workflows and manage related vendors/ consultants for timely deliverables.
• Evaluate, select and manage CROs/ consultants that meet the specific program’s needs and timelines ‘right first time’. Maintain excellent relationships built on transparent and effective communications with external stakeholders.
• Keep abreast with current regulatory and industry practices in clinical pharmacology for biologics development.
• Be a dedicated team player and flexible with constructive feedback from other functional leads unique to each program goals and challenges.
• Excellent program management skills combined with a strong scientific mindset.
• Demonstrated expertise in bioanalytical teams and platforms building/ managing.

Who You Are and What You’ll Bring to Hemab

• Life Sciences Ph.D. plus >6 years or Master’s plus >12 years of progressive experience in clinical bionalysis and/ or pharmacology.
• Prior experience managing/ leading program level clinical bioanalysis and pharmacology deliverables at a Biopharma or Biotech is highly preferred. Alternatively, experience working at CROs leading clinical pharmacology and/ or pharmacometrics workflows for biologics development is also considered.
• Demonstrated expertise in analyzing/ interpreting clinical bioanalytical endpoints (PK, PD and Immunogenicity data) and using them for designing PK-PD modeling and pharmacometrics modules to achieve clinical PoC.
• Prior working experience closely with clinical development, biostats and regulatory teams towards regulatory filings is highly preferred.
• Prior experience managing pharmacology CROs/ consultants is preferred.
• Awareness of Nonclinical PK and toxicokinetic (TK) assessment for regulatory filings is preferred but not a must.
• Cambridge, 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.