Associate Director or Director of Pharmacometrics

vor 6 Stunden

Basel, Schweiz Luzsana Biotechnology (Part of Hengrui) Vollzeit

**Job Title**: Associate Director or Director of Pharmacometrics

**Reports to (Title)**: Head of Pharmacometrics

**Location**: Basel Switzerland

**Direct Reports**: No

**Department**: Clinical Pharmacology & Early Development

Luzsana Biotechnology (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines that are available, accessible, and affordable to anyone, anywhere. The origin of the Luzsana name is rooted in “la luz,” which is Spanish for the light, and “sana,” which is Latin for heal.

Luzsana is a healthcare company that aspires to become a “healing light” across the biotech sector by prioritizing the well-being of all stakeholders it encounters while operating its business. Through a strategic plan with its parent company Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), Luzsana co-develops innovative medicines in areas of high unmet medical need for commercialization in North America, Europe, and Japan.

The company’s pipeline currently includes 11 high-potential oncology and non-oncology programs that span all stages of development from preclinical to phase 3, which it intends to further diversify over time. These programs aim to address areas of high unmet medical need, some with first-in-class or best-in-class potential.

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 organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**Job summary**:
collaboration with various stakeholders. The incumbent will be responsible for
developing compound-specific Pharmacometrics strategy for the development of a
compound including innovative approaches and leads the regulatory strategy for Clinical Pharmacology. 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
- Proficiency in PK, PK/PD, and model-informed drug development (MIDD) principles and analyses.
- Serves as a modeling and simulation (M&S) representative on project teams

interacting with clinical, pre-clinical, biostatistics, and regulatory agents,
as well as CROs.
- Plan, analyze and report population PK/PD, exposure-response, and disease progression models to support dose selection, trial design and Go/No-Go decisions throughout the drug discovery and development process.
- Prepare pharmacometrics reports, manuscripts and documents for publications and regulatory submission.
- Continuously improve the efficiency and effectiveness of the M&S capability by

supporting training activities, keeping abreast of the regulatory guidelines,
and incorporating new modeling tools and methodologies as appropriate.
- Present Clinical Pharmacology and Pharmacometrics function on cross-functional drug development teams and regulatory submissions.
- Responsible for the selection and management of CROs for pharmacometric studies from conception through final report (analysis plan development, budget, timeline, data transfer, data analysis/interpretation, report writing, etc).
- Assess and recommend doses/regimens for first-in-man (FIH) studies, Phase 2, Phase 3, and dose justification in labeling.
- Interact with the asset development team to support the design and interpretation of Clinical Pharmacology and pharmacometrics studies, to prepare the regulatory dossier and respond to reviewer queries.
- Contribute to the preparation/editing/review of documents for regulatory submission (i.e., study reports, IBs, INDs, meeting information packages).
- Responsible for the selection and management of CROs for pharmacometric studies from conception through the final report (analysis plan development, budget, timeline, data transfer, data analysis/interpretation, report writing, etc).io governance meetings.

**Requirements**:
Experience / Education
- A Ph.D. or an equivalent degree in Pharmaceutical Sciences, Pharmacometrics,

Clinical Pharmacology, Mathematics, Statistics, or other quantitative disciplines with an emphasis on Pharmacometrics and PKPD modeling. An MSc degree with relevant experience is also considered.
- PhD: 5 years (Associate director) or 8 years (Director)
- MSc: 8 years (Associate director) or 12 years (Director)

Knowledge / Skills /

**Abilities**:

- Excellent hands-on skills in Pop-PK and PKPD modeling, PBPK modeling, clinical trial simulations etc, preferably for the development of both small and large molecules.
- Strong proficiency in the use of at least one of the modeling tools (e.g., NLME, NONMEM, R, Phoenix WinNonlin etc).
- Working knowledge of health authority perspective on the use of modeling and simulation.
- Experienc

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