Associate Director – Pharmacometrician

🕒 May 7

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 Description

• **Your main responsibilities will include, but are not limited to:** • Lead and perform population pharmacokinetic analyses using advanced modeling tools and methodologies • Develop and implement innovative approaches to improve the efficiency and accuracy of pharmacokinetic analyses • Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize PK sampling and dosing strategies • Provide strategic advice to clients, assume responsibility for deliverables, and develop clinical pharmacology plans • Write and review pharmacokinetic reports and the clinical pharmacology sections of regulatory documents • Represent clients in interactions with regulatory authorities and contribute to business development and relationship management

🎯 Requirements

• **To succeed, we are looking for the following qualifications and attributes:** • Degree in life sciences, healthcare, and/or business administration • At least 6 to 10 years of relevant professional experience, including drug development, clinical pharmacology, and pharmacometrics • Regulatory experience, including preparation of regulatory reports, is essential. Experience with regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), regulatory meetings, and marketing authorization submissions (NDA/BLA/MAA) • Proficiency with NONMEM, Pirana, and R is preferred • Excellent organizational, negotiation, and financial management skills

🏖️ Benefits

• **Benefits of working at Allucent include:** • Comprehensive benefits package by site • Competitive salaries by site • Departmental budget dedicated to training and study to support professional development • Flexible working hours (where reasonable) • Opportunity for remote/hybrid work depending on the site • Leadership and mentoring opportunities • Participation in our mentorship program for new and existing employees • Opportunities for internal mobility and career progression • Financially attractive employee referral program