P2604 - Principal Clinical Pharmacologist at Debiopharm

Lausanne, Vaud, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

30 Aug, 26

Salary

0.0

Posted On

01 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Population PK/PD, Modeling & Simulation, Non-Compartmental Analysis, GCP, GCLP, GLP, Regulatory Guidelines, Antibody Drug Conjugate Development, Protocol Writing, Clinical Trial Management, English Communication, Cross-functional Collaboration, Project Management

Industry

Pharmaceutical Manufacturing

Description

Debiopharm is privately-owned Swiss biopharmaceutical company committed to research in Oncology and Infectious diseases to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Efficacy is our mode of action, saving lives our collective target. Join our team at Debiopharm where together, we innovate, we impact, and we grow. For our Clinical Pharmacology & Pharmacometrics Unit organization based at our Headquarters in Lausanne, we are looking for a Principal Clinical Pharmacologist In this role, you will be the leader for developing the clinical pharmacology scientific strategy for assigned projects in Oncology and/or Infectious diseases. To that aim, you will manage, conduct and supervise clinical pharmacology activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine. Your responsibilities will be but not limited to: · Work in close collaboration with the project team and develop the clinical pharmacology strategy for assigned projects in Oncology or Infectious diseases · Manage the clinical pharmacology activities of assigned projects, by contributing to the design of clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug inter- actions, PK in special populations, …) · In collaboration with the pharmacometricians, elaborate the pharmacometrics strategy and organize the pharmacometrics activities for the assigned projects · Be a member of the Clinical Trial team, contribute to the protocol writing and manage the PK and PK/PD analyses (noncompartmental analyses and modeling approaches) and reporting; manage the risk of food-drug interactions and drug-drug interactions regarding concomitant medications. · Manage the outsourced activities, from provider selection until completion of project · Prepare the clinical pharmacology and pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities · Contribute and participate to scientific communication and events · As part of Debiopharm’s model, contribute to the In & Out licensing activities or external fund- raising activities Your profile · PhD (PharmD is a plus) in Life sciences, pharmacokinetics, clinical pharmacology, or a related discipline · At least 7-year experience in clinical pharmacology within Translational R&D and early clinical phases of drug development · Expertise in Pharmacometrics such as Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation · Excellence knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines · Experience in Antibody Drug Conjugate development is an asset · You are used in working in cross-functional team and fast-paced environment · Team player, looking to tackle challenges together with your team · Excellent communication skills in English (oral and written), French is an asset Debiopharm can offer you · An international and highly dynamic environment, with a long-term vision. · The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry. · The possibility of being in a company in which innovation, people and entrepreneurship are the fundamentals of its success. The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly to present candidates. 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. Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.

Responsibilities

Lead the clinical pharmacology scientific strategy for oncology and infectious disease projects. Manage clinical pharmacology activities, including study design, pharmacometrics strategy, and regulatory documentation.