Sr Manager/AD Clinical Pharmacology
We are seeking a highly experienced Associate Director of Clinical Pharmacology to lead and oversee our clinical pharmacology programs. The ideal candidate will have a strong background in pharmacokinetics, pharmacodynamics, and model-based drug development. This role requires excellent leadership, communication, and problem-solving skills. If you're passionate about advancing drug development and making a significant impact in the field, we encourage you to apply. Key Responsibilities: Develop and execute clinical pharmacology strategies for drug development programs. Oversee the design, conduct, and analysis of clinical pharmacology studies. Collaborate with clinical, regulatory, and scientific teams to support drug development. Provide expert guidance on pharmacokinetics, pharmacodynamics, and modeling and simulation. Ensure compliance with regulatory requirements and industry standards. Mentor and lead a team of clinical pharmacologists. Qualifications: Ph.D., Pharm.D., or equivalent in pharmacology, pharmaceutical sciences, or a related field. Extensive experience in clinical pharmacology and drug development. Proven track record of successful leadership in clinical pharmacology. Strong analytical, communication, and organizational skills. Ability to work collaboratively in a fast-paced, dynamic environment.
US$190000 - US$220000 per year
New York
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Director Pharmacometrics PKDM
Location: MA Or NJ Client: Major Pharmaceutical Company Full Time, Direct Hire The team is looking for an experienced clinical pharmacologist to join their Pharmacokinetics, Dynamics & Metabolism department as the Director of PKDM. You will serve as the clinical PK/PD expert participating in multidisciplinary teams for clinical phase development projects in a range of therapeutic areas. This position is based out of MA OR NJ. Join their team to shape the future of medicine and accelerate drug discovery and development. Key Responsibilities: Formulate drug development questions and create quantitative pharmacology strategies for programs in all stages of development, ranging from first in human dosing through life cycle management Serve as a PKDM representative on multidisciplinary project teams, advancing drug candidates from IND to successful approval. Design, plan, and oversee clinical studies, including PK/PD analysis, interpretation, and reporting. Apply quantitative modeling and simulation skills for dose selection and addressing complex issues in drug development. Contribute to clinical pharmacology sections of regulatory documents and respond to regulatory inquiries. Qualifications: Extensive experience in clinical development including PK/PD concepts and modeling & simulation strategies to support drug development Education: Ph.D. with or without post-doctoral experience plus at least twelve (12) years of relevant experience Demonstrated experience in interacting with and influencing regulatory agencies worldwide such as FDA, EMA and PMDA. Ability to work collaboratively in multidisciplinary teams Join my client and make a difference in the lives of patients and their families! Apply to learn more about this ground breaking opportunity!
US$220000 - US$240000 per year + Bonus
United States of America
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Food Auditor - Netherlands
Position Overview: The Food Auditor will be responsible for conducting audits of food manufacturing and processing facilities to ensure compliance with food safety and quality standards. This role involves detailed assessments, reporting, and providing guidance to clients to improve their food safety practices. Key Responsibilities: Conduct comprehensive audits of food manufacturing and processing facilities to assess compliance with food safety standards, regulations, and best practices. Evaluate processes, procedures, and documentation related to food safety, quality management systems, and hygiene practices. Identify non-conformities, potential risks, and areas for improvement, and provide clear and actionable feedback to clients. Prepare detailed audit reports, summarizing findings, observations, and recommendations. Liaise with clients to discuss audit results, provide guidance on corrective actions, and follow up on implementation. Stay updated with current and emerging food safety regulations, standards, and industry practices. Maintain accurate and organized records of audit activities and findings. Participate in training and professional development activities to enhance auditing skills and knowledge. Collaborate with internal teams to share insights and contribute to continuous improvement initiatives. Qualifications: Bachelor's degree in Food Science, Microbiology, Food Technology, or a related field. Minimum of 4 years of experience in food safety, quality assurance, or food auditing. In-depth knowledge of food safety standards and regulations, such as HACCP, ISO 22000, BRC, and FSSC 22000. Certification as a lead auditor in one or more food safety standards is preferred. Strong analytical and problem-solving skills. Excellent written and verbal communication skills in both Dutch and English. Ability to work independently and manage time effectively. Attention to detail and strong organizational skills. Willingness to travel to various client sites within the Netherlands. Key Competencies: Regulatory Expertise: Thorough understanding of food safety standards and regulations. Technical Proficiency: Ability to interpret and assess complex processes and procedures. Communication: Clear and effective communication with clients and internal teams. Analytical Thinking: Strong analytical skills for evaluating food safety and quality management systems. Detail-Oriented: High attention to detail in audit activities and reporting. Team Collaboration: Ability to work collaboratively within a team environment. Benefits: Competitive salary and performance-based incentives. Comprehensive health and wellness benefits. Professional development and training opportunities. Supportive and collaborative work environment. Opportunity to work with leading food manufacturing and processing companies.
Negotiable
Netherlands
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Senior Director, Clinical Pharmacology & Pharmacometrics
***This is position is based in the West Coast and will require to report on-site.*** Position Summary: EPM Scientific is seeking a Senior Director of Clinical Pharmacology & Pharmacometrics to lead and expand our clinical pharmacology programs. In this critical role, you will be responsible for driving the strategic and operational aspects of clinical pharmacology and pharmacometrics to support our growing pipeline of RNAi-based therapeutics. You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and research, to ensure the successful advancement of our innovative therapies through clinical development. Key Responsibilities: Lead the design, execution, and interpretation of clinical pharmacology studies, including first-in-human, dose-ranging, drug-drug interaction, and special population studies. Develop and implement clinical pharmacology and pharmacometrics strategies to support clinical development programs from preclinical through late-stage development. Oversee the development of population pharmacokinetic and pharmacodynamic models to inform dose selection, optimize dosing regimens, and support regulatory submissions. Collaborate with clinical development teams to design and analyze clinical trials, ensuring robust pharmacokinetic/pharmacodynamic (PK/PD) data collection and interpretation. Provide scientific and strategic leadership in interactions with regulatory agencies, including preparation and review of regulatory submissions, meeting packages, and responses to regulatory queries. Mentor and develop a high-performing team of clinical pharmacologists and pharmacometricians, fostering a culture of scientific excellence and innovation. Stay abreast of emerging trends and advancements in clinical pharmacology, pharmacometrics, and RNAi therapeutics to ensure the application of best practices and novel approaches. Qualifications: PhD, PharmD, or MD in pharmacology, pharmacokinetics, pharmaceutical sciences, or a related field. A minimum of 10 years of experience in clinical pharmacology and pharmacometrics within the biotechnology or pharmaceutical industry. Demonstrated experience in the design and execution of clinical pharmacology studies and the development of pharmacokinetic/pharmacodynamic models. Proven track record of successfully supporting drug development programs and regulatory submissions. Strong leadership and team management skills, with the ability to mentor and develop junior scientists. Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and present complex scientific data to diverse audiences. Deep understanding of regulatory requirements and guidelines related to clinical pharmacology and pharmacometrics.
US$280000 - US$300000 per year
United States of America
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