Senior Pharmacokinetics expert

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

In the Senior Pharmacokinetics expert role, you will work in our Clinical Pharmacology & DMPK team, in close collaboration with our local and international clients, being responsible for leading and managing pharmacokinetic activities throughout the drug development lifecycle—ensuring scientific excellence, regulatory compliance, and efficient project delivery. The role offers significant opportunity to shape and influence your area of responsibility within Clinical Pharmacology and DMPK, depending on your expertise and background

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 Contract Research Organizations (CROs).
• Author or oversee the preparation of pharmacokinetic-related sections in regulatory documents such as IMPDs, NDAs, and MAAs.
• Provide strategic input for regulatory interactions and submissions related to pharmacokinetics.

Desired qualifications

• PhD in a relevant scientific field.
• 5–10+ years of industry or authority experience within pharmacokinetics.
• Advantageous to have experience across several drug classes such as small molecules, biologics, peptides, oligonucleotides, ATMPs, and/or vaccines.
• Advantageous to have experience of modelling and simulation to support dosage selection, PKPD and/or PBPK.
• Experience of using WinNonlin software
• Understanding of regulatory expectations within the relevant field.
• Experience with global regulatory submissions such as IND, IMPD, etc.
• Excellent communication and technical writing skills.
• Proficiency in Microsoft Office applications.
• Fluent in a Nordic language and English.

Personal Characteristics

• Proactive, collaborative, and scientific mindset.
• Strong relationship-building and coordination skills.
• Focusses on client needs, with strong communication and presentation skills.
• Well-organized, able to work both independently and within teams.

LINK Medical offers

We offer an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees in an international environment and values as honest and open communication are essential. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation, benefit scheme and great development opportunities for all employees.

Contact Information

If you would like to know more or if you have any questions about the position, please contact:

Ulrika Andersson, Senior Director Drug Development, [phone], [e-mail]

Last day for application: 15 November, 2026