Director, Clinical Pharmacology

Vor 4 Tagen

Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit

**Job Title**: Director, Clinical Pharmacology

**Reports to (Title)**: Department Head of Clinical Pharmacology & Early Development

**Location**: Basel Switzerland

**Direct Reports**: TBD

**Department**: Clinical Pharmacology & Early Development

**About Hengrui**:
The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success. Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally.

Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, antivirals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.

We recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing ex-China organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**About this job**:
Pharmacometrics knowledge, including pharmacokinetics/pharmacodynamics analyses and principles of model-based drug development in the programs for all stages of drug development, in collaboration with various stakeholders. The incumbent will provide Clinical Pharmacology expertise on the Global Program Team and execute the day-to-day operations for the Clinical Pharmacology aspects of the assigned programs. In addition, this role is accountable to support the early development of portfolios by defining and developing the early development strategies including PoC of a clearly differentiated asset and enables accelerated
development and seamless transition to late-stage development and NDA/BLA filing.

Tasks

**Essential Job Functions**:

- Oversees all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK,

PK/PD and regulatory submissions.
- Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements; manages clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
- Leads study design, execution and reporting of clinical pharmacology/poof-of-concept studies. Provides input into all phases of drug development including, but not limited to proof-of-concept, dose-finding, dose optimization, exposure-response and pediatric development.
- Performs and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond

FIH (dose/exposure-response analyses to guide dose regimen from pre-proof-of-concept (POC) and POC studies).
- Applies the understanding of (1) the impact of intra

physiology and/or pathology, concomitant medication use, and biopharmaceutics,
on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission
processes.
- Author/reviewer of clinical pharmacology submission documents and representative of the department at the different product development team.
- Lead development of clinical pharmacology sections for study design, protocol

development, study execution, reporting, interpretation of data, regulatory
and pediatrics development plans.
- Closely interacts with non-clinical and bioanalytical team members for on activities

related to assay development, sample management, pharmacogenomics and biomarker
development to design and execution of first-in-human, mass balance, drug-drug
interaction, special population, TQT, and PoC studies.
- Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and

early phase assets.
- Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations

and biowaivers for pre-and post-approval formulations.
- Prior experience interacting effectively and successfully with regulatory agencies is essential.

**Requirements**:
Experience / Education
- A Ph.D. or PharmD or MD equivalent degree in Pharmacokinetics, Pharmaceutical

Sciences, Clinical Pharmacology, Pharmacology, or a related area with a minimum
of 8 years of experience in these areas.

**Knowledge / Skills / Abilities**:

- Understanding of the overall process of drug development and the R&D process is required.
- Understanding of PK, PD, PK/PD, and Translational Medicine is required.
- Ability to interpret PK and PK/PD results and prepare presentations to illustrate

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