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Key skills for this role
This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy.
You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions.
In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.
Your main responsibilities will include but not limited to:
• Lead and conduct population PK analyses using advanced modeling tools and methodologies
• Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
• Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
• Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
• Author and review PK reports and clinical pharmacology sections of regulatory documents
• Represent clients in regulatory interactions and contribute to business development and relationship management
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Life science, healthcare and/or business degree
Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
Proficiency in NONMEM, Pirana, and R software preferred
Excellent organizational, negotiating and financial skills
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we SHINE. Find more information about our values.
If you are interested in this role please apply through the button or for more information reach out to Demetria Eggleston at Demetria.eggleston@allucent.com
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our global offices .
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
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The Full-Service CRO Partner for Biopharma Clinical Development
Visit company websiteJobs and hiring trendsFull-time
Senior · 10+ years experience
Remote
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