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 DMPK, you will be responsible for planning, managing, and delivering the DMPK strategyacross discovery and early clinical development for asset(s) in our pipeline. This includes oversight of ADME, PK, bioanalysis, and human PK prediction to enable informed candidate selection and clinical development decisions.
- You will work closely with external collaborators (CROs and consultants) and internal cross-functional teams(nonclinical, clinical pharmacology, toxicology, CMC, regulatory, and quality) to support study design, workflows, and regulatory filings.
- Your role will be essential in building and expanding Hemab’s DMPK capabilities, offering significant opportunities for scientific and leadership growth.
At Hemab, we foster an environment where everyone can wear multiple hats depending on experience, motivation, and program needs. We celebrate achievements collectively and value continuous feedback to strengthen our fast-paced, cross-functional culture.
What You’ll Do at Hemab
- Spearhead and execute the DMPK strategy from late discovery / IND-enabling stages through early clinical development.
- Serve as the DMPK lead supporting candidate selection, first-in-human dose projections, clinical PK strategy, and regulatory documentation.
- Design, oversee, and interpret in vitro and in vivo ADME, PK, and bioanalytical studies in collaboration with CROs and internal teams.
- Lead human PK prediction efforts, including allometry and model-informed approaches, to support dose selection and clinical planning.
- Provide DMPK input to IND-enabling packages, including nonclinical summaries, bioanalytical strategies, and PK-related regulatory sections.
- Partner cross-functionally with toxicology, clinical pharmacology, CMC, regulatory, and quality to ensure integrated development strategies.
- Evaluate, select, and manage DMPK CROs and consultants to meet program-specific scientific and timeline requirements.
- Maintain strong, transparent relationships with external stakeholders to ensure high-quality and timely deliverables.
- Stay current with regulatory expectations and industry best practices in DMPK for biologics development.
- Contribute scientific expertise to regulatory interactions and submissions, including IND and related agency communications.
- Be a collaborative team player, open to constructive feedback, and adaptable to evolving program goals and challenges.
- Apply strong program management skills combined with scientific rigor and strategic thinking.
Who You Are and What You’ll Bring to Hemab
- Education: PhD or equivalent in Pharmaceutical Sciences, Pharmacokinetics, DMPK, Chemistry, or a related field.
- Experience: Minimum of 6–8 years of relevant industry experience in DMPK within pharmaceutical or biotechnology settings.
- Prior experience leading DMPK strategy at the program level in Biopharma/Biotech is highly preferred.
- Demonstrated expertise in ADME, PK, and bioanalytical data interpretation and applying these insights to inform candidate selection and development decisions.
- Strong foundation in pharmacokinetic principles, with hands-on experience in study design, data analysis, and interpretation.
- Proven experience working cross-functionally with toxicology, clinical pharmacology, CMC, and regulatory teams toward IND submissions.
- Prior experience managing DMPK CROs and consultants is preferred.
- Experience with biologics PK, bioanalysis, and immunogenicity-related considerations is preferred.
- Awareness of toxicokinetics (TK) and nonclinical PK requirements for regulatory filings is preferred.
