Director Clinical Pharmacology

Vor 3 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

**Director Clincial Pharmacology**

The role:
This role has a significant impact on the company's products, by supporting clinical execution of Clinical Pharmacology studies clinical development programs in accordance with the Clinical Development Plan and Clinical Pharmacology Plan.

**Responsibilities**:

- Overall accountability for clinical pharmacology strategies and activities in appointed clinical
- Provide matrix leadership to collaborate, align and influence across the cross-functional teams to identify and mitigate key project issues related to the clinical pharmacology discipline (PK, PK/PD, metabolism, including modeling and simulation[M&S])
- Provide expert knowledge in clinical pharmacology and clinical PK to the projects and communicate clinical pharmacology and clinical PK aspects internally and during health authority interactions.
- Define appropriate strategies for clinical pharmacology/translational medicine, clinical PK, PK/PD and M&S in clinical development plans.
- Oversee that Model Based Drug Development (MBDD) is applied in clinical programs when clinically relevant.
- Ensure translational aspects are taken into account and that pre-clinical and clinical PK/PD information are optimally used and integrated into early and late phase development
- Contribute and decide on the biomarker strategy in clinical
- Contribute to the clinical development
- Responsible for clinical pharmacology sections in regulatory documents and at interactions with regulatory authorities during all phases of drug development.
- Represent clinical pharmacology on project Core
- Contribute to clinical pharmacology evaluations at in-licensing and due-diligence

**Profile**:

- 8 years of experience in clinical pharmacology research (preferably in the pharmaceutical industry) or a minimum of Master´s degree in relevant scientific area with 10 years of experience in clinical pharmacology research (preferably in the pharmaceutical industry).
- Experience with biologics and small molecules is required.
- Experience in late phase clinical trial.
- Solid understanding of the drug-development process and issues specific to clinical pharmacology of biotechnology products.

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