Associate Director, Pharmacometry

Marcum Search is seeking a full time Senior Manager/Associate Director, Pharmacometry for our Pharmaceutical client in Northern NJ. Our client is looking for a highly motivated scientist to work in a dynamic, cross-functional environment within the clinical development team. The successful candidate will be responsible for developing the pharmacometry strategy for the clinical programs developed by our client. The candidate will be responsible for the construction, validation and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions in close collaboration with the clinical team and the other functions within Clinical Pharmacology (i.e., Clinical PKPD and Biomarkers/ Pharmacogenomics). This position will report to the Head of Clinical Pharmacology.

Responsibilities

• Lead design and execution of model based drug development strategy using quantitative approaches for developing programs and addressing complex questions as needed
• Manage pharmacometric analyses done by external vendors
• Integrate, interpret and report results to project teams and other customers as needed
• Provide input into relevant clinical and regulatory documents including clinical study protocols/reports, modeling reports, investigator brochures, IND and NDA's within agreed timelines and meeting all regulatory requirements in consultation with manager
• Ensure constructive collaboration within drug development teams and with other internal worldwide partners
• Monitor timelines and objectives and ensure accuracy of project and activity progress for pharmacometric analyses
• Assure rapid and effective communication of high-quality data and results to project/clinical teams
• Maintain and enhance technical and drug development expertise (e.g., training courses, external meeting attendance)
• Act as technical subject matter expert internally and externally

Qualifications

Education:

• PhD (strongly preferred) in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biostatistics, Biomedical Engineering.

Experience

• 2 to 8 years of industry experience in pharmacometrics in clinical pharmacology and/or clinical PK/PD
• Extensive hands-on experience with population PK and PK/PD modeling using NONMEM and other software
• Excellent writing and verbal communication skills
• Ability to work in a matrix environment and with different leadership styles
• Proven ability to work independently, proactively and effectively
• Brand Pharma or CRO experience is a MUST

For consideration you can directly email your resume to Laurie.Hills@MarcumSearch.com with Pharmacometry in subject line.

Marcum Search is an Equal Opportunity Employer
Marcum Search does not discriminate on the basis of race, ancestry, national origin, color, religion, gender, age, marital status, sexual orientation, disability, veteran status, or any other protected classification under the law.