Director, Clinical Pharmacology

Vor 4 Tagen

Basel, Schweiz Luzsana Biotechnology (Part of Hengrui) 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

Luzsana Biotechnology (Luzsana), is a global, purpose-driven innovative medicines

company committed to delivering medicines that are available, accessible and

affordable to more people around the world. Luzsana, a wholly-owned subsidiary

of Hengrui Pharma, is a global development and commercialization biotechnology

organization. Luzsana has developed a strategic plan with Hengrui Pharma that

provides the company access to a world-class pipeline of more than 250 clinical

studies in areas of high unmet medical need, such as oncology, cardiovascular,

metabolic/diabetes, pain management, immunology and liver and renal disease.

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

**Job summary**:
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

findings accurately are required.
- Excellent working knowledge of phase I clinical operations, drug development,

multi-region regulatory requirements and PK/PD analysis.
- Working knowledge of the clinical and regulatory landscape, disease processes and

mechanisms, available treatment paradigms, and patient populations is required.
- Has established a level of expertise and scientific reputation through publications

and/or presentations preferred.
- Good working knowledge of formulation development, drug development and clinical development.
- Hands-on pharmacometrics skills with Nonmen, R, Phoenix Winnolin, or NLME (preferred).
- Strong organization skills. Strong communication skills.
- Flexibility to react rapidly to changing situat

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