Clinical Pharmacologist
vor 1 Woche
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Clinical Pharmacology & Pharmacometrics Unit within the Translational Medicine organization based at our Headquarters in Lausanne, we are looking for a
Clinical Pharmacologist
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficacy is our mode of action, saving lives our collective target.
In this role, you will contribute to the development of clinical pharmacology and pharmacometrics
scientific strategy and manages assigned clinical pharmacology and pharmacometrics activities to add
value to, support, and accelerate the development of Debiopharm’s innovative therapeutics.
**Your responsibilities will be but not limited to**:
Manage the clinical pharmacology and pharmacometrics activities in clinical studies:
Participate in the study design with regard to clinical pharmacology aspects
Participate in the preparation of clinical protocols, ICFs, Investigator's Brochure, SAP, CSR, and regulatory documents (IMPD, IND)
Determine, implement and manage the PK or PK/PD data analyses and reporting according to GCPs and regulatory guidelines
Contribute to the medical data review with regard to clinical pharmacology aspects (risk of drug-drug interactions and management of concomitant medications)
Be a member (as Clinical Pharmacologist) of one or more Clinical Study team(s)
Participate to the design, plan and manage (oversight of contractors when applicable) the pharmacometrics studies (Non-Compartmental PK analysis, Population PK, PK/PD, Exposure/Response, PBPK, Modeling & Simulation) of Debiopharm's compounds in development
Manage finance, budget and timelines related to assigned clinical pharmacology and pharmacometrics activities
Contribute and participate to scientific communications and events
Contribute to in/out licensing activities and external grant-seeking activities
**Requirements**:
**Your profile**:
PharmD, PhD or an equivalent degree in pharmacokinetics, pharmacology, life sciences or a related discipline with a minimum of 2 years professional or industry experience in clinical pharmacology or pharmacometrics
In depth understanding of pharmacology and pharmacokinetic concepts, as well as preclinical and clinical development
Knowledge of GCP, GCLP and relevant regulatory guidelines
Able to work in cross-functional team and fast-paced environment
Strong organizational skills and ability to handle multiple tasks simultaneously
Excellent presentation capabilities and communication skills in English (oral and written)
This position is office based, with up to 40% home-office
**Benefits**:
**Debiopharm offers employees**:
International, highly dynamic environment with a long term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
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