Senior Clinical Pharmacologist

Placements24; Queenstown (MD); On-site; USD 72,000 - 108,000; Full time

Benefits offered by this job

Competitive salary package

Health insurance

Retirement plan

Professional development

Job summary

Our client, a distinguished pharmaceutical company focused on innovative therapeutics, seeks a Senior Clinical Pharmacologist to join their Queenstown, Eastern Cape team. You will design and oversee clinical pharmacology studies, evaluate PK/PD data, and support regulatory submissions such as IND and NDA.

The ideal candidate holds a PhD or PharmD with postdoctoral experience and has 6+ years in clinical pharmacology, with strong PK/PD modeling skills (NONMEM, Phoenix WinNonlin).

Qualifications

• PhD/PharmD with postdoctoral fellowship or equivalent research experience.
• Minimum 6 years in clinical pharmacology with PK/PD analysis and trial design.
• In-depth knowledge of FDA/EMA regulatory processes and GCP.
• Experience with clinical trial management and data interpretation.
• Proficiency with PK/PD modeling software (NONMEM, Phoenix WinNonlin) is desirable.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Design and develop clinical pharmacology strategies and study protocols.
• Oversee execution of clinical pharmacology studies with adherence to protocols and GCP.
• Analyze PK/PD data from clinical trials.
• Develop and validate bioanalytical methods with labs.
• Use modeling/simulation to characterize drug behavior in populations.
• Contribute to safety assessments and regulatory submissions.
• Prepare clinical pharmacology summaries and study reports.
• Collaborate with cross-functional teams across drug development.

Skills

Analytical skills

Communication skills

Project management

Team collaboration

Education

PhD or PharmD with postdoctoral fellowship or equivalent

Tools

NONMEM

Phoenix WinNonlin

Job description

About the Role

Our client, a distinguished pharmaceutical company focused on innovative therapeutics, is seeking a highly experienced Senior Clinical Pharmacologist to join their esteemed team in Queenstown, Eastern Cape. This crucial role involves contributing to the design and execution of clinical pharmacology studies that underpin drug development. The ideal candidate will possess a deep understanding of pharmacokinetic (PK) and pharmacodynamic (PD) principles, clinical trial design, and regulatory requirements. You will be instrumental in evaluating the safety and efficacy of new drug candidates, interpreting clinical data, and providing critical insights to guide drug development strategies. This position offers a significant opportunity to impact patient care through advancements in pharmaceutical science.

Key Responsibilities

• Contribute to the design and development of clinical pharmacology strategies and study protocols.
• Oversee and manage the execution of clinical pharmacology studies, ensuring adherence to protocols, GCP, and regulatory guidelines.
• Analyze and interpret pharmacokinetic (PK) and pharmacodynamic (PD) data from clinical trials.
• Develop and validate bioanalytical methods in collaboration with bioanalytical laboratories.
• Utilize modeling and simulation techniques (e.g., population PK/PD modeling) to characterize drug behavior in different patient populations.
• Assess the safety and tolerability of investigational drugs, contributing to risk-benefit evaluations.
• Prepare clinical pharmacology summaries, regulatory submission documents (e.g., IND, NDA), and study reports.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, biostatistics, and drug safety.
• Stay current with scientific literature, regulatory guidelines, and emerging trends in clinical pharmacology.
• Provide scientific and strategic input on drug development programs.

Requirements

• PhD or PharmD with relevant postdoctoral fellowship or equivalent research experience in pharmacology, clinical pharmacology, or a related biomedical science.
• A minimum of 6 years of experience in clinical pharmacology, with a strong focus on PK/PD analysis and clinical trial design.
• In-depth knowledge of drug development processes, regulatory requirements (FDA, EMA), and Good Clinical Practice (GCP).
• Experience with clinical trial management and data interpretation.
• Proficiency in PK/PD modeling software (e.g., NONMEM, Phoenix WinNonlin) is highly desirable.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to present complex data effectively.
• Proven ability to work collaboratively in a team environment and manage multiple projects.
• Experience with regulatory submissions is a significant advantage.

Benefits

• Our client offers a competitive salary package, commensurate with your expertise and experience, along with performance-based incentives.
• Comprehensive health insurance coverage, including medical, dental, and vision plans, is provided.
• Generous paid time off, including annual leave, sick leave, and public holidays, ensures a healthy work-life balance.
• Opportunities for professional growth and development, such as attending scientific conferences and continuing education, are actively supported.
• This role is based in a modern facility in Queenstown, Eastern Cape, fostering a dynamic and collaborative research environment.
• Retirement savings plans are also available.