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, +46 76 492 4518, Ulrika.andersson@linkmedical.eu All applications are treated confidentially and will be evaluated when received, so please apply as soon as possible. Please submit your application in English. Last day for application: 15 November, 2026
This position is open at our office in Copenhagen, Denmark. LINK Medical Research is searching for a highly motivated fulltime CRA at our office in Copenhagen, Denmark. As a CRA, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. You may also be outsourced to clients in the greater Copenhagen area and the position will involve frequent travelling related to monitoring visits. Responsibilities · Plan and perform site feasibility, initiation, monitoring, and close-out activities in accordance with the protocol, ICH-GCP, applicable regulations, monitoring plans, and SOPs · Perform Source Data Verification (SDV) and review of Case Report Forms (CRFs) · Preparation, handling and distribution of clinical study supplies and products when applicable · Comply with applicable timelines, agreements and budget · Maintain TMF completeness and inspection readiness and support trial supplies, informed consent materials, and regulatory submissions · Assess and escalate study risks, issues, and deviations and provide transparent progress reporting · Act as the main contact for assigned sites, support participant recruitment and retention, and train site staff Desired qualifications · Basic education within relevant field, equivalent to degree from University or University level. Formal education may be compensated by experience. · Up to date on ICH-GCP including national regulatory requirements · Experienced in monitoring studies or running clinical studies and in investigator site management · Must be fluent in Danish (required) and English · Good writing skills in both Danish and English · Effective verbal and written communication · Generally good IT skills and use of standard office tools Personal Characteristics · Service minded with good cooperation and communication skills, as well as oral and written presentation skills · Well organized and structured, able to work both independently and in teams · Independent, flexible, accurate, and solution oriented 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 Director of Clinical Operations Trine Dyring, +45 4127 8470, trine.dyring.jensen@linkmedical.eu All applications are treated confidentially. Last day for application: 30th of October 2026.
This position is open in one of our offices in Sweden (Uppsala, Stockholm, Lund), Norway (Oslo) and Denmark (Copenhagen). LINK Medical is searching for a Senior QA Manager with a strong background in GCP, preferably combined with GMP experience. As our company continues to grow and expand its portfolio of cross-functional projects, we are looking for a highly motivated Senior QA Manager to join our team. In this role, you will work on QA projects in close collaboration with the customers ensuring compliance with applicable GxP requirements and industry standards. You will play a key role in developing and strengthening LINK Medicals QA capabilities, with a primary focus on GCP and preferably clinical-phase GMP activities according to the customer’s needs. The position also offers opportunities to contribute to business development in close collaboration with members of several teams across the LINK Medical organization. Responsibilities · Provide QA expertise in customer services and projects within GCP preferably in combination with GMP for clinical phase. This may include QMS development, auditing, training and advising in quality-related matters. · Fulfilling certain roles at the customer, e.g. Quality Manager, Qualified Person (QP) as applicable, based on the competency of the consultant. · Cooperate with colleagues in LINK Medical, nationally and internationally. · Manage and execute projects in an efficient and timely manner and within budget. · Develop training material and conduct internal and external training. · Keep updated on quality-related regulations and topics. · Contribute to the development of LINK Medical’s business for quality assurance services Desired qualifications · Natural science degree at college/university level · More than 7 years’ experience from quality assurance within the life science industry · Broad knowledge of quality assurance and regulatory requirements · In depth knowledge within GCP in addition to knowledge within GMP and possibly other GxPs. · Experience in auditing and quality system development · Fluent in one of the Scandinavian languages and English · Good IT skills and use of standard office tools Personal characteristics · Takes initiative, acts with confidence and works independently · Takes responsibilities for actions and projects · Develops job knowledge and expertise through continual professional development. · Shares expertise and knowledge · Demonstrates an interest in and understanding of others, motivates and builds team spirit · Be flexible, structured, effective and customer focused. · Identifies and creates business opportunities · Performs high quality work while maintaining professionalism and a courteous attitude with clients and colleagues LINK Medical offers LINK Medical offers an exciting and challenging position in a European CRO and Regulatory Service Provider that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees. Contact information If you would like to know more or have any questions about the position, please contact Tina Madsen, Director QA Operations (tina.madsen@linkmedical.eu). All applications are treated confidentially. Last day for submitting your application: 2026-10-11
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