||Clinical Pharmacology Scientist
||Directly report to:
||Director, Clinical Pharmacology
SUMMARY OF RELEVANT JOB RESPONSIBILITIES
The Clinical Pharmacology Scientist is a scientific and leadership role who will work closely with the Head of Clinical Pharmacology to ensure all phases of clinical development including the design and implementation of clinical protocols and development plans are achieved. This role provides an exciting opportunity to make a strategic and scientific impact in a growing development organization, on current and future clinical programs. The ideal candidate will help to build clinical pharmacological expertise and be able to collaboratively design, plan, implement, analyze, and report clinical studies. This is a unique opportunity to expand your knowledge in the scientific and research aspects in oncology across multiple disease areas working on several assets, through day-to-day activities and close interactions with the Research and Discovery teams within Hutchison MediPharma (US) and teams in Shanghai, China.
RESPONSIBILITIES AND DUTIES
- Represent Clinical Pharmacology on development project teams, leading the development of clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and the execution of clinical pharmacology studies.
- Contribute to the development of clinical pharmacology study concepts and protocols, data analysis, clinical study reports, and relevant components of regulatory submission documents.
- Support clinical pharmacology-related components of other clinical studies, including protocols, study conduct, data analysis, and report-writing.
- Establish clinical pharmacology timelines to support compound development plans, consistent with overall business plan in collaboration with other functional areas.
- Coordinate and supervise all outsourced clinical pharmacology deliverables and ensure all activities are in alignment with the department’s strategy and in compliance with regulatory and legal requirements, and with company’s operating procedures (OPs).
- Collaborate with DMPK to ensure that validated/qualified bioanalytical methods are available for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies.
- Conduct or oversee pharmacokinetic (PK)/pharmacodynamic (PD) and dose-exposure-response analyses (in-house/outsourced) to support dose selection, trial design, internal decision-making, regulatory submission documents, and publications.
- Represent Clinical Pharmacology in interactions with and responses to regulatory agencies.
- Assist Head of Clinical Pharmacology to manage resource, budget and project planning across HMP portfolio.
- Provide input on preclinical-stage programs to optimize in vitro & preclinical data supporting the advancement of programs into clinical development and the submission of Investigational New Drug applications.
- Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice, internal OPs, regulations for specific projects to which assigned, and therapeutics knowledge in terms of both medical background and clinical trial design.
- MS, PhD, or equivalent degree in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or Biological Sciences, or a PharmD degree.
- For Associate Director level, MS or PharmD degrees with at least 8 years or PhD degree with at least 5 years of pharmaceutical development experience.
- For Director level, MS or PharmD degrees with at least 12 years or PhD degree with at least 8 years of pharmaceutical development experience.
- Prior experience in oncology drug development would be an asset.
- Demonstrated understanding of clinical pharmacology and translational medicine.
- Good understanding of global clinical trials and drug development, including in Clinical Pharmacology, from Phase I through Phase IV (post-marketing).
- Good knowledge of US, European, and Asian regulatory requirements and guidelines.
- Strong project management and organizational skills, as well as a high level of proficiency with problem solving, conflict resolution, negotiation and team building skills.
- Solid understanding of all functional area responsibilities associated with clinical development process.
- Demonstrated ability to translate strategy into action and analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Ability to anticipate, recognize and resolve problems/issues that may impact timelines and deliverables.
- Actively builds relationships and networks with others across and beyond HMP.
- Ability to work constructively across organizational boundaries and manage conflicts/issues with internal and external partners and customers.
- Experience in working in a multi-national, matrix environment consists of internal/external colleagues and stakeholders.
- Excellent skills in oral and written communication.
- Proficiency with pharmacokinetic software programs (e.g. Phoenix WinNonlin) and graphic software packages (e.g. SigmaPlot).
- Working knowledge of PBPK and PK/PD modeling and simulation software packages such as GastroPlus, SimCYP, NONMEM, PDxPop, R.
Other Job Requirements
- Flexibility to work across different time zones
- Estimated travel of about 5% of time