Assistant Director, Clinical Pharmacokinetics
The Clinical Pharmacology and Pharmacometrics Organization leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics. The organization supports all phases of pharmaceutical research and development from Discovery to Development to On Market Support for all new molecular entities and marketed products in all therapeutic areas (antiviral, immunoscience, neuroscience, pain, metabolic disease, men and women's health, renal disease and oncology). The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for defining the relationship between drug exposure and safety measures (clinical outcomes or biomarkers (e.g., QTc)) to identify populations that may be at risk of increased toxicity or decreased tolerability. CPPM performs the selection, design and interpretation of all Phase I studies including first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot/ definitive cardiovascular (QTc), special population, pharmacogenetic and immunogenicity studies. The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success for achieving Target Product Profile (TPP). CPPM contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, pharmaceutical manufacturing and regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts.
Independently conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Responsible for leading Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects of all Abbott projects along with CPPM management. Independently conducts due diligence. Manages personnel (PK Associates through Group Leaders) including development, mentoring, and effective delegation.
Key Responsibilities Include:
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Contributes to commercial and regulatory strategies by leading and formulating complicated Clinical Pharmacology plans including development activities. Develops Clinical Pharmacology plans, timelines and priorities of studies to satisfy regulatory expectations and defends plans and interpretation of data to regulatory agencies.
- Provides expert PK/PD/ Clinical Pharmacology and strategic consultation to GPRD, GPRA, and all levels of management on critical decisions and development plans for multiple projects within or across multiple therapeutic areas.
- Develops productive collaborations and communications with other groups across multiple disciplines. Highly effective writer and communicator of Clinical Pharmacology research or other regulatory materials.
- Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Serves as liaison to other departments /divisions for any study/project needs
- Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information including use of therapeutic area databases.
- Independently conducts due diligence.
- Is the Subject Matter Expert for Clinical Pharmacology interpretations of reports for regulatory filings and clinical protocols.
- Provides critical interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions. Is the primary author in high-impact factor peer-reviewed journals, R&D reports, and/or regulatory documents/filings.
- Manages of one or more Clinical Pharmacology programs, including personnel development, mentoring and effective delegation to direct reports to meet goals.
- Uses an external information network to gain competitive intelligence and act as advocate for integrating this knowledge into the project team's research efforts.
- PhD in field related to Pharmacokinetics.
- 2-5 years experience in drug development and/or department operations. Proven record of successful projects.
- Advanced knowledge of and experience in multiple therapeutic and/or functional areas. Experience across range of development phases preferred.
- Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion. Must have demonstrated exemplary PK/PD experience in managing and completing multiple complex projects or equivalent experience.
- Knowledge and understanding in application of standard business procedures (regulatory guidances, global regulations, ethical issues associated with clinical studies, SOPs).
- Proven track record of successful projects (report/submissions delivered on time, high quality).
- Participated in and is key contributor to initiatives and advancement of CPPM as an organization.
- Builds/drives inter-department relationships and teamwork. Anticipates and leads issue resolution. Identifies opportunities for, and leads teams for process improvement initiatives.
- Actively participates in risk assessment and development of contingency plans.
- Connects scientific and business implications from multiple teams and links to overall strategy.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled