Sr. Director, Pharmacometrics (USA)

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

To be successful you will possess:

• 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

Benefits of working at Allucent include:

• 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

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”