Associate Director or Director of Bioanalytical

Vor 4 Tagen

Basel, Schweiz Hengrui USA Vollzeit

**Reports to (Title): Head of Bioanalytical Sciences**
**Location: Basel Switzerland**
**Direct Reports : No**
**Department: Clinical Pharmacology & Early Development**

**Job Summary**:
Hengrui USA & EU is seeking a highly motivated individual with a strong background in Bioanalytical Sciences to support our rapidly growing clinical development portfolio. The incumbent will provide scientific leadership of the global Bioanalytical Sciences group (US and EU) across Hengrui's research and development programs. The incumbent will lead bioassay method development, transfer, and validation under GLP and GCLP guidelines. As the key contributor in Bioanalytical Sciences group, the incumbent will direct the CROs in the development and validation of bioanalytical methods to measure drug concentrations and immunogenicity in all nonclinical and clinical studies across the entire pipeline of small molecules and biologics.

**Essential Job Functions**:

- Be responsible for Bioanalysis, programmed outputs, and integrated scientific reports for clinical trial results for assigned projects.
- Leads the method development, transfer and validation of bioassays (LBA, cell-based, and LC-MS) for PK, ADA and biomarker analysis in clinical studies.
- Acts as a member of global project team and provides relevant expertise to the team on the development, verification, and validation of biological assays for PK, PD, and biomarkers.
- Proactively identify clinical study bioassay implementation challenges and propose plans to mitigate challenges
- Partners with Ops colleagues to support executional delivery of bioassay test, sample collection, storage and shipping and ensures that all activities are conducted in compliance with relevant regulatory requirements.
- Reviews and approves bioassay SOPs and method validation reports, independently analyses, interprets, and presents results from bioanalysis and draws scientifically valid conclusions that support and enable decision making.
- Monitors the execution of bioassay plans to ensure project timelines are met. Timely provide updates to internal stakeholders
- Implements study-specific bioassay data oversight and quality plans. Works closely with data management and coordinate bioassay data transfers to clinical database during clinical studies
- Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines.
- Manage CRO contracts and bioanalytical aspects of project budgets.
- Contribute to the preparation of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and address relevant queries from regulatory agencies.
**Job Requirements**:
**Experience / Education**
- PhD with at least 5 years (Associate Dir) or 8 years (Dir) or MS with at least 8 years (Associate Dir) or 12 years (Dir) of experience working at a pharmaceutical company in chemistry, analytical sciences, pharmaceutical sciences, or a related area.
- Management experience includes leadership of technical teams, project management, and research in the GLP environment is desirable.
**Knowledge / Skills / Abilities**:

- Knowledge and understanding of established and new assay technologies such as IHC, PCR, LBA, LC-MS, etc. preferred.
- Experience preparing bioanalytical sections of regulatory submission documents (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols.
- Ability to work effectively in a matrix environment and across multiple countries and cultures.
- Excellent oral and written communication skills, with ability to transfer complex analysis, concepts and ideas into a clear message.
- Skillful in use of interpersonal and influencing skills to accomplish work without formal authority.
- Ability to travel up to 20% as needed.
**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 discriminated against on the basis of disability

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