Senior Director, Pharmacometrics Lead

3 weeks ago

Toronto, Ontario, Canada Allucent Full time
Job Title: Senior Director, Pharmacometrics

We are seeking a highly experienced Senior Director, Pharmacometrics to join our team at Allucent. As a Senior Director, Pharmacometrics, you will be responsible for providing strategic leadership and direction to the Pharmacometrics team within the Clinical Pharmacology, Modeling and Simulation (CPMS) area.

Key Responsibilities:
  • Lead the Pharmacometrics team in the development and implementation of population PK analysis approaches to increase the efficiency and accuracy of population PK analysis.
  • Direct and/or conduct population PK analysis using appropriate software, including NONMEM and R.
  • Develop novel population PK analysis approaches to increase the efficiency and accuracy of population PK analysis.
  • Assist in the design, analyze, and interpret clinical pharmacology studies, including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.
  • 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.

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