Scientist, Clinical Pharmacology and Pharmacometrics

vor 2 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

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 & Drug Metabolism organization based at our Headquarters in Lausanne, we are looking for a

Scientist, Clinical Pharmacology and Pharmacometrics

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 finance, budget and timelines related to assigned clinical pharmacology and pharmacometrics activities
Design, plan, manage (oversight of contractors when applicable) and report the pharmacometrics studies (Non-Compartmental PK analysis, Population PK, PK/PD, Exposure/Response, Probability of Target Attainment, PBPK, Modeling & Simulation) of Debiopharm's compounds in development
Manage the clinical pharmacology and pharmacometrics part of assigned clinical studies
Participate in the study design with regard to clinical pharmacology aspects
Participate in the preparation of informed consent forms, clinical protocol, SAP and CSR, and other study-related documents
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)
Ensure adequate filing of pharmacometrics study documents in the e-TMF
Be a member (as Clinical Pharmacologist) of one or more Clinical Study team(s)
Manage outsourcing activities to an international network of CROs (Europe, Asia and America) or through academic collaborations (preparation of RFP, contractors selection, contracts review and budget negotiation)
Contribute to the preparation of clinical pharmacology and pharmacometrics documentations to support the cross-functional activities (including PK chapters of regulatory documents)
Participate in external scientific communications (publications, poster and oral presentations, and press releases)

Contribute to in/out licensing activities and external fund-raising activities

**Requirements**:
PharmD, PhD or an equivalent degree in pharmacokinetics, pharmacology, life sciences or a related discipline with a minimum of 5 years experience in clinical pharmacology or pharmacometrics within Translational R&D
Excellence knowledge of GCP, GCLP, GLP and ICH guidelines
Knowledge of Regulatory Affairs (EMA, FDA ) is a plus
First experience in project management
Strong communication & presentation skills
Very good communication & influencing skills (oral and written)
Fluency in English (both oral and written)
Strong team player, looking to drive further projects and innovation
This position is office based, with up to 40% home-office

**Benefits**:
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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