Job Number: 445509
Associate Director, Clinical Pharmacology
Our client is looking for a highly qualified and skilled professional for the permanent salaried role of Associate Director, Clinical Pharmacology in King of Prussia, Pennsylvania. The Associate Director, Clinical Pharmacology will be responsible for full clinical pharmacology (including pharmacometrics) aspects of global programs. We are looking for someone with a minimum four years of experience contributing to the clinical pharmacology aspects of clinical drug development.
- Lead the clinical pharmacology and pharmacometrics strategy for a portfolio program
- Responsible for the design of clinical pharmacology studies or protocol sections throughout all stages of drug development
- Provide oversight for implementation of studies together with Clinical Development, Clinical Safety and Clinical Research Operations
- Independently plan and implement all relevant PK-PD analyses
- Handle 'hands-on' modelling & simulation activities for assigned projects
- Lead the high quality review and interpretation of clinical pharmacology study results
- Oversee presentation in clinical study reports and related study documentation
- Implement the use of innovative analytical methods such as pharmacometrics, modeling and simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of study designs
- Provide effective clinical pharmacology contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings
- Provides resolution of clinical pharmacology queries from regulatory agencies, setting strategy to and writing responses to regulatory queries
- A minimum 4 years' experience, specifically contributing to the clinical pharmacology aspects of clinical drug development
- Advanced understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development
- PhD/PharmD or recognized medical degree (MD)
- Clinical pharmacology research fellowship favorable
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.