Senior Director - Pharmacometrics

September 29

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Allucent

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Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000

Description

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. • We are looking for a Senior Director, Pharmacometrics to join our A-team (hybrid*/remote). • As a Senior Director, Pharmacometrics at Allucent, you are responsible for providing strategy and leadership to the Pharmacometrics team within the Clinical Pharmacology, Modeling and Simulation (CPMS) area. • Responsibilities include directing or conducting modeling and simulation analyses, providing strategic advice to clients, collaborating with and mentoring other pharmacometricians, and representing clients at meetings with regulatory agencies. • In this role your key tasks will include: • Line management of the pharmacometrics team at Allucent. • Direct and/or conduct population PK analysis using appropriate software • Develop novel population PK analysis approaches the increase the efficiency and accuracy of population PK analysis • Assist in the 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 advice to clients, develop clinical pharmacology strategic plans, and take ownership/responsibility for client deliverables • Work with other consultants to prepare and review PK reports and other clinical pharmacology documents • Author clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc. • Represent clients at meetings with US and ex-US regulatory agencies • Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies • Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal company guidances to be able to contribute ideas to improve technologies and procedures for PK practices • Support business development and marketing activities, foster client relationships, and bring new clients into the consulting firm • Maintain up-to-date training on appropriate company SOP's and guidances

Requirements

• Life science, healthcare and/or business degree • Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics • Demonstrable hands-on experience of population PK, exposure-response, and PK/PD modeling in a clinical setting • Solid understanding of the principles of model-informed drug development (MIDD) and its practical delivery. • Excellent technical and programming skills with population analysis and other software, including NONMEM and R as a minimum. Experience with Monolix suite, PKSim, Phoenix Winnonlin and python is a plus. • Prior line management experience is a plus. • Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions. • Experience of collaborating in and leading matrix teams including junior modelers, programmers and other technical and project management staff. • Strong analytical skills • Strong written and verbal communication skills including good command of English language • Representative, outgoing, and client focused • Ability to work in a fast-paced challenging environment of a growing company • Administrative excellence • Proficiency with various computer applications such as Word, Excel, and PowerPoint required • Strong leadership skills • Effective at problem solving, strategic thinking, and conflict resolution • Strong presentation and networking capabilities • Excellent organizational, negotiating, and financial skills

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our enriching Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees