Associate Director or Director of Pharmacometrics

vor 23 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 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**:
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.
- Experience in implementing pharmacometrics analysis and reporting to regulatory agencies for the NDA/BLA submission is preferred.
- Ability to quickly adjust to shifting priorities and demanding timelines when necessary.

An Equal Opportunity Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and will not be
discr

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