Director, Clinical Pharmacology & PK-PD Modeling

Hemab Therapeutics; København; Presencial; DKK 600.000 - 900.000; Jornada completa

Descripción de la vacante

Hemab Therapeutics in Copenhagen, Denmark, seeks a Director of Clinical Pharmacology to lead PK/PD strategy across pre-Phase 1/2 through pivotal studies and regulatory submissions.

You will collaborate with CROs and internal teams to design studies, perform pharmacometrics, guide PoC, and ensure robust regulatory filings while expanding in-house capabilities.

This role offers significant leadership opportunities in a dynamic, fast-paced culture focused on advancing therapies for rare disorders.

Formación

• Minimum of 6 years of experience in clinical pharmacology and pharmacometrics within the pharmaceutical or biotechnology industry.
• Experience leading program-level clinical pharmacology deliverables in Biopharma or CROs is highly preferred.
• Demonstrated expertise in analyzing PK/PD endpoints and using them for modeling and pharmacometrics.
• Experience with regulatory filings and cross-functional collaboration with clinical development, biostatistics, and regulatory teams.

Responsabilidades

• Spearhead and execute the clinical pharmacology strategy from pre-Phase 1/2 through pivotal studies and approvals.
• Lead clinical pharmacology efforts for PoC establishment, dosing recommendations, and regulatory filings by collaborating with internal and external partners.
• Oversee PK-PD modeling and pharmacometrics workflows and manage vendors/consultants for timely deliverables.
• Design and oversee PK/PD studies to support dose selection, safety assessments and efficacy evaluations.
• Evaluate and manage CROs/consultants to meet program needs and timelines.
• Maintain strong relationships with external stakeholders through clear, proactive communication.
• Stay current with regulatory and industry practices in biologics development and regulatory filings.

Conocimientos

Clinical pharmacology

Pharmacometrics

PK-PD modeling

CRO management

Regulatory filings

Cross-functional leadership

Program management

Educación

PhD in Clinical Pharmacology or Pharmacometrics

Descripción del empleo

Hemab Therapeutics in Copenhagen, Denmark, seeks a Director of Clinical Pharmacology to lead PK/PD strategy across pre-Phase 1/2 through pivotal studies and regulatory submissions.

You will collaborate with CROs and internal teams to design studies, perform pharmacometrics, guide PoC, and ensure robust regulatory filings while expanding in-house capabilities.

This role offers significant leadership opportunities in a dynamic, fast-paced culture focused on advancing therapies for rare disorders.