Job Description:

Job Title: Senior Director Clinical Pharmacology (SDCP)

Job Location: US - Remote

Job Type: FTE or Contractor

Job Overview:

Under Clinical Sciences, the Senior Director Clinical Pharmacology (SDCP) has a pivotal role in providing strategic guidance on Clinical Pharmacology (CP) development, scientific informatics, and regulatory writing capabilities to support our clients. Responsibilities include daily operation of CP, interaction with key clients, function operation management, and supporting business development.

Special Requirements - Must be able to support clients in China.

• This will include the ability to read and write in Mandarin
• Must be available to have video meetings with Clients who reside in China

Job Duties and Responsibilities:

• Guide strategic planning for CP development.
• Set up business model, workflow, and performance management to meet CP developing goals.
• Lead a group of clinical pharmacologists to provide CP-related scientific expertise on clinical projects in various therapeutic areas.
• Guide/review study design, dose selection, protocol, analysis plan, data analysis, and report.
• Ensure team daily operation and deliverables in an efficient, high quality, and timely manner.
• Manage project assignment, resource allocation, issue identification, and resolution.
• Ensure implementation of CP best practices.
• Review/write working instruction (WI) and guidance (WG), standard operating procedure (SOP), template, and training.
• Lead CP to support business development (BD).
• Provide consulting, proposals, and scientific solutions to support BD.
• To be involved in bidding and provide quotations.
• Provide CP leadership to support partner lines.
• Coordinate/cooperate statistics, programming, data management, medical, medical writer, and safety expert to ensure appropriate PK/PD result output and data presentation.
• Lead CP to provide support in various regulatory interactions.
• Review/write CP-related documents of pre-IND, IND, NDA/BLA submission.

Supervisory Responsibilities:

• Manages and coaches directly a team of Clinical Pharmacologies, with clear goal settings and performance review
• Provides work direction and oversight of team’s daily work

Job Requirements:

Education

• Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacy, or related discipline

Experience

• At least 10 years experience in clinical pharmacology
• Demonstrated success in leading clinical pharmacology activities
• Sophisticated knowledge and skills in pharmacokinetics/pharmacodynamics and drug metabolism
• Experience in one or multiple therapeutic areas and ability to handle contributions to multiple clinical pharmacology programs simultaneously
• Demonstrated understanding of model-based drug development principles and applications
• Solid knowledge of ICH/GCP/FDA/EMA/CDE regulations and guidelines and/or other countries/regions' regulatory requirements and guidelines

Skills/Competencies

• Demonstrated strategic thinking and planning skills
• Deep insight into CRO business and knowledge of pharmaceutical industry
• Ability to mentor other junior scientist staff and manager in CP
• Experience in interactions with regulatory agencies (FDA, EMA, CFDA)
• Excellent communication and customer-oriented relationship management skills
• Excellent English language skills in both verbal and written
• Ability to forge and maintain client relationships
• Ability to perform client-facing tasks
• Stay on the edge of the industry, technology, and regulatory development.

Capabilities

• Advanced knowledge and application of a broad range of CP tools, including but not limited to Phoenix WinNonlin, NONMEM, SAS, R, and other related software
• Ability to work on the CP KPIs and resource planning
• Ability to work in a digital environment using computer systems
• Ability to work within a team
• Ability to manage a team
• Ability to work remotely
• Ability to travel as needed

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