Director, Clinical Pharmacology

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 Pharmacology, you will be responsible for planning, managing and delivering the clinical pharmacology strategy through execution of pharmacokinetics (PK), pharmacodynamics (PD), 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 Clinical Pharmacology 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. 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 pharmacology strategy beginning in pre-phase 1/2 and through pivotal studies and approvals.
• Contribute as clinical 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.
• Design and oversee pharmacokinetic and pharmacodynamic studies to support dose selection, safety assessments, and efficacy evaluations.
• Evaluate, select and manage CROs/consultants that meet the specific program's needs and timelines.
•  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.
• Provide clinical pharmacology expertise for regulatory interactions and submissions, including IND, NDA/BLA filings.
• 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.

Who You Are and What You'll Bring to Hemab?

• Education: PhD or equivalent in Clinical Pharmacology, Pharmacometrics, or a related field.
• Experience: Minimum of 6 years of experience in clinical pharmacology and pharmacometrics within the pharmaceutical or biotechnology industry.
• Prior experience managing/leading program level clinical 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 pharmacology endpoints (PK, PD data) and using them for designing PK-PD modeling and pharmacometrics modules to achieve clinical PoC.
• Strong background in pharmacokinetic and pharmacodynamic principles, with hands-on experience in study design, data analysis, and interpretation.
• Prior working experience closely with clinical development, biostats and regulatory teams towards regulatory filings is highly preferred.
• Prior experience managing clinical pharmacology CROs/consultants is preferred.
• DMPK (Drug Metabolism and Pharmacokinetics) expertise and bioanalytical experience are preferred and would be valuable additions to the role.
• Experience with immunogenicity assessments for biologics is preferred.
• Awareness of Nonclinical PK and toxicokinetic (TK) assessment for regulatory filings is preferred but not a must.