Senior Pharmacokinetics Lead

LINK Medical AS; København; On-site; DKK 850,000 - 1,250,000; Full time

Job summary

LINK Medical AS is seeking a Senior Pharmacokinetics expert to lead PK activities within Clinical Pharmacology & DMPK. The role involves guiding drug metabolism strategies, PK analyses, and regulatory submissions for global development programs, collaborating with local and international clients.

You will oversee PK modelling, support CRO coordination, and contribute to regulatory document preparation. Fluency in a Nordic language and English is expected.

Qualifications

• PhD in a relevant scientific field.
• 5–10+ years of industry or authority experience in pharmacokinetics.
• Experience with modelling and simulation for dosage selection, PKPD, PBPK.
• Experience with regulatory submissions (IND, IMPD, etc.).
• Excellent communication and technical writing skills.
• Fluent in a Nordic language and English.

Responsibilities

• Provide expert scientific and regulatory guidance on drug metabolism and pharmacokinetics (DMPK) and clinical pharmacology aspects of drug development programs.
• Conduct or oversee pharmacokinetic (PK) calculations, modelling, and analyses to support development decisions.
• Support clients in the selection, management, and coordination of activities with CROs.
• Author or oversee the preparation of PK-related sections in regulatory documents such as IMPDs, NDAs, and MAAs.
• Provide strategic input for regulatory interactions and submissions related to pharmacokinetics.

Skills

Communication skills

Technical writing

Microsoft Office

Education

PhD in a relevant scientific field

Tools

WinNonlin

Regulatory submissions (IND/IMPD/NDA)

Job description

LINK Medical AS is seeking a Senior Pharmacokinetics expert to lead PK activities within Clinical Pharmacology & DMPK. The role involves guiding drug metabolism strategies, PK analyses, and regulatory submissions for global development programs, collaborating with local and international clients.

You will oversee PK modelling, support CRO coordination, and contribute to regulatory document preparation. Fluency in a Nordic language and English is expected.