Senior Director, Pharmacometrics

1 month ago

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

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

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

Key Responsibilities:
  • Direct and/or conduct population PK analysis using appropriate software
  • 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 (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

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