Senior/Principal Scientist, Clinical Pharmacology Full-time

Roche Clinical Pharmacology Scientist

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The Position

The Clinical Pharmacology (CP) Scientist is responsible for developing and implementing quantitative Clinical Pharmacology strategies across early to late phases of clinical drug development to ensure that the right drug is administered to the right patient at the right dosing regimen and to deliver an optimal therapeutic benefit/risk profile for the patients. The CP Scientist uses state of the art modeling and simulation tools and is able to implement model-informed drug development strategies to address critical questions that are aligned with project needs. The CP Scientist is an active member of cross-functional drug development teams, and works in close partnership with Pharmacometricians, Biostatisticians, Clinicians, Biomarker Scientists, Toxicologists, Preclinical Pharmacologists, and other function) to support drug development decisions through registration and post-marketing commitments. The Senior/Principal CP Scientist represents CP function on filing teams and fosters effective collaboration and communications with regulatory agencies to support efficient drug development of drug candidates.

Key responsibilities include:

• Leading the design and review of clinical study protocols for the development of novel therapeutic agents with particular focus on China development (all drug and delivery modalities);
• Leading the planning and conduct of PK/PD data analyses and setting strategy to foster the appropriate use of modeling and simulations to inform clinical drug development decisions;
• CP functional representation and leadership at functional and cross-functional China development focused meetings internally and externally (eg. cross-functional teams, department meetings, governance review meetings, scientific conferences, etc.);
• Implementing strategic agility and effective project management to align critical CP deliverables according to the rapidly evolving regulatory and project needs in China;
• Authorship of regulatory documents and meeting background packages to support key clinical development milestones in China;
• Lead CP representation at health-authority meetings in China, and contribute to the planning, implementation and organization of regulatory filings (e.g. IND, BLA, NDA, sNDA);
• Support the global development strategies for clinical pharmacology and M&S as needed.

Technical Skills:

• The ability to plan, organize, interpret, and/or perform PK/PD data analyses.
• Familiarity with clinical drug development and clinical study design options for development of different drug and delivery modalities.
• Familiarity with quantitative modeling approaches in drug development and working knowledge of relevant modeling software (e.g. NONMEM, WinNonlin, R, SimCYP, GastroPlus, PKSim, Matlab, etc).
• Familiarity with agentic approaches for work streamlining and integrating agent-based workflows to improve efficiency throughout the drug development lifecycle.
• Working knowledge of statistical approaches as they apply to clinical study design and analysis.

Desired:

• Experience in leading regulatory filing strategy as a CP lead to support the totality of CP filing package, dose/regimen justification, and drug labeling is highly desired.

Communication Skills:

• Excellent written communication skills, in order to deliver high quality protocols, publications, and regulatory documents for team and management review.
• Excellent oral communications to make clear presentations and foster effective stakeholder engagement.

Drug Development Knowledge:

• Relevant experience/knowledge of how CP science can impact drug development is required.
• Good knowledge of GCP and working knowledge of relevant regulatory guidelines is required.

Scientific Leadership:

• Strong leadership skills and experience in representing CP in cross functional project teams.

Qualifications:

• PhD, PharmD, MD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related quantitative discipline
• Job level will depend on the years of experience and the totality of scientific influence

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Roche is an Equal Opportunity Employer.