Hemab Therapeutics is looking for a Director of Clinical Bioanalysis and DMPK

Hemab Therapeutics is looking for a Director of Clinical Bioanalysis and DMPK; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Join a pioneering biotech company on a mission to address rare bleeding disorders as the Director of Clinical Bioanalysis and DMPK. In this pivotal role, you will lead the bioanalysis and pharmacology strategy, ensuring the success of clinical studies from inception to approval. Collaborate with talented cross-functional teams and external partners to drive innovation in biotherapeutics. This is an exciting opportunity to make a significant impact in a dynamic and supportive environment where your expertise will be valued and your career can flourish.

Qualifications

• 6+ years of experience in clinical bioanalysis and pharmacology.
• Expertise in PK, PD, and immunogenicity analysis.
• Experience with regulatory filings and CRO management.

Responsibilities

• Lead clinical bioanalysis and pharmacology strategy from pre-phase 1/2 through pivotal studies.
• Manage CROs and consultants for timely deliverables.
• Collaborate with cross-functional teams for study design and execution.

Skills

Clinical Bioanalysis

Pharmacology

PK-PD Modeling

Regulatory Filings

Program Management

Education

Ph.D. in Life Sciences

Master's in Life Sciences

Job description

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Hemab Therapeutics is looking for a 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 internal cross-functional leads (clinical development, clinical operations, biometrics, regulatory, and quality) to assist 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 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

• Spearhead and execute the clinical bioanalysis and/or pharmacology strategy from pre-phase 1/2 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, and regulatory filings by working cross-functionally 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 program’s needs and timelines ‘right first time’. Maintain transparent and effective communication with external stakeholders.
• Stay updated with current regulatory and industry practices in clinical pharmacology for biologics development.
• Be a dedicated team player, flexible, and receptive to constructive feedback from other functional leads based on each program’s goals and challenges.
• Demonstrate excellent program management skills combined with a strong scientific mindset.
• Build and manage bioanalytical teams and platforms effectively.

Who You Are and What You’ll Bring to Hemab

• Life Sciences Ph.D. with >6 years or Master’s with >12 years of progressive experience in clinical bioanalysis and/or pharmacology.
• Experience managing or leading program-level clinical bioanalysis and pharmacology deliverables at a Biopharma or Biotech company is highly preferred. Alternatively, experience working at CROs leading clinical pharmacology and pharmacometrics workflows for biologics development is also considered.
• Expertise in analyzing and interpreting clinical bioanalytical endpoints (PK, PD, Immunogenicity) and using them for PK-PD modeling and pharmacometrics modules to achieve clinical PoC.
• Experience working closely with clinical development, biostatistics, and regulatory teams towards regulatory filings is highly preferred.
• Experience managing pharmacology CROs/consultants is preferred.
• Knowledge of nonclinical PK and toxicokinetic (TK) assessments for regulatory filings is a plus but not mandatory.
• Candidates based in Cambridge, USA, or Copenhagen, Denmark are preferred, but not mandatory. The role requires on-site presence at one of these locations.

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