Remote Clinical Pharmacologist

Placements24; Sandton; Hybride; ZAR 900 000 - 1 500 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Health benefits

Bonus program

Learning opportunities

R&D resources

Résumé du poste

Placements24 is seeking an experienced Remote Clinical Pharmacologist to lead early drug development activities. The role emphasizes design and interpretation of Phase I trials, PK/PD modeling, and regulatory documentation in a fully remote setting.

The ideal candidate holds a PhD/MD-PhD in Pharmacology with 7+ years in pharmaceutical research, and excellent communication skills for cross-functional collaboration and regulatory interactions.

Qualifications

• PhD or MD/PhD in Pharmacology or related discipline.
• Minimum 7 years of clinical pharmacology drug development experience.
• Strong PK/PD principles and regulatory understanding.

Responsabilités

• Design and develop Phase I pharmacology protocols (FIH, SAD, MAD, DDI).
• Oversee study conduct, ensure adherence to GCP and protocols.
• Analyze PK/PD data and perform population PK modeling.
• Prepare regulatory submissions sections and briefing documents.
• Collaborate with bioanalytical, operations, biostatistics, and regulatory teams.
• Mentor junior pharmacologists and contribute to team development.
• Present findings to internal committees and external forums.

Connaissances

Clinical pharmacology

PK/PD modeling

Regulatory understanding

GxP knowledge

Formation

PhD in Pharmacology

MD/PhD in Pharmacology

Outils

NONMEM

Phoenix WinNonlin

Description du poste

About the Role

Our client, a renowned pharmaceutical research company, is seeking a highly analytical and experienced Remote Clinical Pharmacologist to join their dynamic team. This fully remote position allows you to leverage your expertise in human pharmacology and drug development from anywhere. The Clinical Pharmacologist will play a critical role in designing, conducting, and interpreting Phase I clinical trials, focusing on drug metabolism, pharmacokinetics (PK), and pharmacodynamics (PD). You will collaborate with cross-functional teams to advance drug candidates through the early stages of development, ensuring robust scientific rigor and regulatory compliance. This is an exceptional opportunity for a pharmacologist who thrives in a remote environment and is passionate about contributing to the discovery of novel therapeutics.

Key Responsibilities

• Design and develop protocols for Phase I clinical pharmacology studies, including first-in-human (FIH), SAD, MAD, and drug-drug interaction (DDI) studies.
• Oversee the conduct of clinical pharmacology studies, ensuring adherence to protocols and regulatory guidelines (GCP).
• Analyze and interpret PK/PD data, including population PK modeling and simulation.
• Prepare clinical pharmacology sections of regulatory submissions (e.g., INDs, NDAs) and contribute to briefing documents.
• Collaborate closely with bioanalytical, clinical operations, biostatistics, and regulatory affairs teams.
• Provide scientific and strategic input into drug development plans based on clinical pharmacology data.
• Stay abreast of the latest advancements in clinical pharmacology, PK/PD modeling, and relevant regulatory guidance.
• Review and provide input on investigator brochures and other study-related documents.
• Mentor junior pharmacologists and contribute to the scientific development of the team.
• Present findings and recommendations to internal committees and external scientific forums.

Requirements

• PhD or MD/PhD in Pharmacology, Clinical Pharmacology, or a related discipline.
• Minimum of 7 years of experience in clinical pharmacology drug development within the pharmaceutical industry or a CRO.
• Strong understanding of PK/PD principles, population PK modeling, and bioanalytical methods.
• Proven experience in designing and overseeing Phase I clinical trials.
• Familiarity with regulatory requirements for clinical pharmacology studies (FDA, EMA, ICH).
• Excellent written and verbal communication skills, with the ability to author scientific reports and regulatory documents.
• Strong analytical and problem-solving skills, with experience in data interpretation and statistical analysis.
• Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.
• Experience with non-compartmental analysis (NCA) and population PK modeling software (e.g., NONMEM, Phoenix WinNonlin) is highly desirable.
• Demonstrated ability to collaborate effectively within multidisciplinary teams.

Benefits

This fully remote position offers unparalleled flexibility and the opportunity to work from your preferred location. Our client provides a highly competitive salary, comprehensive benefits package including health, dental, and vision insurance, and an attractive bonus structure. We invest in our employees' professional growth through continuous learning opportunities and access to cutting-edge scientific resources.

• highly competitive salary
• comprehensive benefits package including health, dental, and vision insurance
• an attractive bonus structure
• continuous learning opportunities
• access to cutting-edge scientific resources

Join a world-class organization dedicated to pioneering new medicines from our Sandton, Gauteng hub, impacting global health.