JOB DESCRIPTION

The successful candidate will have a proven track record of working in the clinical PK/translational/clinical pharmacology area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple departments across the organization and developing strategic relationships with preferred vendors. They will work closely with other clinical and nonclinical disciplines and ensure that objectives for programs are achieved.

Key Responsibilities

• Contribute to the design of clinical studies to understand the pharmacokinetics and pharmacology of molecules
• Represent clinical PK/translational/clinical pharmacology in multifunctional development project teams
• Collaborate with other functions, but particularly pharmacology and DMPK/Toxicology to interpret clinical data and establish/refine PK-PD efficacy/safety relationships
• Ensure that appropriate clinical PK/pharmacology studies are included in program plans and timelines
• Generates hypothesis and provides strategy for clinical pharmacology study types e.g., metabolic, drug-drug interaction issues, special populations and safety studies collaborating closely with cross functional colleagues
• Analyze and interpret clinical data using appropriate statistical methods and communicate results to internal and external stakeholders
• Performs advanced/complex PK and PK/PD modeling or exploratory analyses or guide such analyses as appropriate
• Contribute to the cross-functional review of regulatory documents and author and review sections for relevant regulatory documents and be accountable for their quality in support of regulatory submissions
• Serve as a subject matter expert in composing responses to regulatory queries
• Identify, qualify, engage, and manage external providers of PK services; bioanalysis, analysis and interpretation of resulting data
• Provide in-depth scientific expertise and technical leadership as well as resource and relationship management of external networks
• Deliver and communicate results to project teams and other stakeholders to enable decision making
• Recommend, initiate, lead and champion new innovations from external, global and local sources to ensure cutting-edge science is applied to drug project issues
• Provide scientific and clinical input into regulatory submissions, including clinical study reports, briefing documents, and responses to regulatory queries
• Prepares technical reports including clinical study reports

Professional Experience and Qualifications

• PhD or equivalent in a relevant scientific discipline
• A minimum of 10+ years of development experience in pharmaceutical/biotech R&D supporting clinical PK/translational/clinical pharmacology
• Experience conducting or supervising conduct of clinical studies such as drug-drug interaction, special population or bioavailability; supporting other studies such as first-in-human, proof-of-concept or pivotal studies; conducting or supervising conduct of non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic (PD) analyses; contributing to clinical and regulatory documents such as the Investigator's Brochure and contributing to regulatory correspondence
• Strong knowledge of clinical research design, statistical methods, and regulatory requirements
• Strong analytical and problem-solving skills, with attention to detail
• Strong knowledge of pharmacokinetics, pharmacodynamic and bioanalytical principles
• Hands on experience with clinical PK/translational/clinical pharmacology studies and an in-depth understanding of study design, data interpretation and how PK studies contribute to the development process
• Experience working with external vendors to provide PK/PD support for programs
• Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge
• Up to date knowledge on regulatory guidance related to PK/PD support of clinical trials
• Experience designing and critically evaluating results of clinical studies
• Team player with strong negotiation, problem-solving, and strategic influencing skills
• Strong customer focus with the ability to have robust discussions with project leaders and other stakeholders to ensure that project, scientific and resource demands are aligned
• Track record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project context
• Clear and open communication skills, and experience communicating across cross functional partners