Sr Pharmacometrician (Europe) - Allucent

OVERVIEW

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. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.

DESCRIPTION

Bring your expertise to the forefront of innovation. We are looking for a Sr Pharmacometrician to join our A-team (hybrid). As a CRA at Allucent, you are responsible for providing strategy and leadership to the Pharmacometrics team within the Clinical Pharmacology, Modeling and Simulation (CPMS). Responsibilities also 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.

RESPONSIBILITIES

• Direct and/or conduct population PK and PK/PD analysis using appropriate software.
• Develop novel population PK analysis approaches to increase the efficiency and accuracy of population PK analysis.
• Assist in the design of, 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
• Actively contribute to staff learning & development within the company
• Review, evaluate, and approve processes and procedures for the pharmacometrics division within the Quality Management System as required
• Monitor and assure client satisfaction on existing projects for the pharmacometrics division with related activities
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

REQUIREMENTS

• Life science, healthcare and/or business degree
• Minimum 4 years of relevant work experience (industry and academia)
• Required proficiency in NONMEM and R software, experience in MONOLIX is a plus
• Strong analytical skills, strategic thinking and effective at problem solving
• Strong written and verbal communication skills including good command of English language
• Ability to work in a fast-paced challenging environment of a growing company
• 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 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