ADME specialist and DMPK project team lead

Job description
Are you an ADME specialist and DMPK project team lead? We are now looking for a new team member for our client IRLAB Therapeutics AB in Gothenburg. IRLAB Therapeutics is a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease. Their drug portfolio comprises two Phase IIb drug candidates, two preclinical candidates preparing for Phase I studies, and a well-advanced discovery project. They have discovered and generated all their drug candidates and continue to discover innovative drug candidates for the treatment of CNS disorders through their proprietary systems biology-based Integrative Screening Process (ISP) research platform. You will work in projects covering the whole area from early discovery to clinical development


Why working at IRLAB Therapeutics AB:
Rooted in Nobel Prize-winning research, IRLAB has grown rapidly to become recognized and respected as a world leader in understanding the complex neuropharmacology of CNS disorders and especially Parkinson’s disease. IRLAB has a well-defined, strategically focused R&D pipeline of powerful new treatments targeting the various stages of Parkinson’s as they worsen over time throughout the patient’s journey of neurodegeneration. Having a full range of effective disease management options for Parkinson’s patients is regarded as essential by both the medical and patient communities – and at the same time potentially a blockbuster pharmaceutical business. IRLAB is listed on Nasdaq Stockholm. More information on: www.irlab.se.


If you are ready to make a difference and join IRLAB exciting growth journey, apply before the 30th of September 2024. Selection and interviews will be ongoing. This is a permanent full time position and the starting date will be agreed upon by all parties. For more information: Please contact Meriem Echbarthi, PhD meriem.echbarthi@randstad.se."
Please note that applications sent through email will not be processed and deleted due to GDPR.


Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal and professional development are in focus, and you are offered a large network and many social activities.

Responsibilities
You would have the responsibility for:
• Developing DMPK project strategies and proposals and present these to the project teams and management board.
• Lead the DMPK team to ensure smooth planning and conduct of studies in preparation and follow-up of project team decisions.
• Supervise or perform human PKPD and dose predictions based upon preclinical in vivo and in vitro data to support clinical dose selection and trial design.
• Evaluation of clinical PK data, including simulation of different dosing scenarios/populations.
• Be member of the clinical project group. Prepare DMPK project and compound documentation such as internal reports, regulatory documents e.g., IMPD, IND and Investigator brochure. Active participation in interactions with regulatory authorities including meetings and correspondence, relating to ADME/DMPK matters.
• Collaborate as leader and/or team member in multidisciplinary teams on drug development topics.
• Responsible for planning, coordination and evaluation of DMPK studies performed in house in close collaboration with the members of the DMPK team.
• Responsible for planning of DMPK studies externally at contract laboratories (CROs) worldwide through establishing contact and close collaboration via email contact and video meetings. Responsible for reviewing the results and reports of such studies.
• Share knowledge and lessons learned in the DMPK team and company. 

Qualifications
• Ph.D (or equivalent industrial experience) in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics)
• Long-standing experience (10+ years) in clinical/ non-clinical DMPK with a broad understanding of all DMPK related subdisciplines (i.e. Pharmacokinetics, Toxicokinetics, PK/PD relationships and modelling, In vitro and in vivo ADME, Drug Metabolism, Bioanalysis of small molecules)
• Deep knowledge of regulatory clinical research and clinical data.
• Creating, collecting and reviewing essential documents required for IB, IND and IMPD release.
• Ability to work in and lead project teams.
• High accessibility to all hierarchy levels.
• Very good organizational and communication skills. 
• English: fluent in speaking, reading, writing. 

About the company

Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.