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Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

The Associate Director, Translational PK/PD Modeling is responsible for providing scientific expertise and strategy to the Model-Informed Drug Development (MIDD) division within the Clinical Pharmacology, Modeling and Simulation (CPMS) business unit. Responsibilities include directing or conducting translational PK, PK/PD and early clinical pharmacometrics modeling and simulation analyses, providing strategic advice to clients, collaborating with and mentoring other translational modelers & pharmacometricians, and representing clients at meetings with regulatory agencies.

Location: United States (Remote)

Responsibilities:

• Direct and/or conduct translational, ie. pre-clinical and early clinical PK & PK/PD analysis using population and other approaches with appropriate software
• Develop novel approaches for planning, analysis, & reporting the increase the efficiency and accuracy of translational/early clinical PK, PK/PD analysis
• Assist in the design, analysis, and interpretation of translational, early clinical & clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize design, data collection and dosing strategies
• Provide strategic advice to clients, develop translational, entry-into human and early clinical model-informed drug development strategic plans, and take ownership/responsibility for client deliverables
• Prepare and review translational and early clinical modeling reports and other clinical pharmacology documents
• Author translational/ 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
• 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 translational and broader
• 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
• Monitor and assure client satisfaction on existing projects for the MIDD division with related activities
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

• Review, evaluate, and approve processes and procedures for the MIDD division within the Quality Management System as required

• Contribute to other areas of business as required

Requirements

Qualifications

• PhD/PharmD/Higher degree in life sciences/engineering/mathematics relevant to translational PK/PD modeling/pharmacometrics
• Minimum 5 years of relevant work experience, including hands-on experience in drug development, translational modeling & pharmacometrics including extrapolating pre-clinical PK, PD and efficacy data to human to inform clinical trial design and program development
• Demonstrated hands-on experience with population analysis approaches using software packages NONMEM, Monolix and R essential
• Strong analytical skills

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

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes

Equal Employment Opportunity and Affirmative Action

Allucent LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Cato Research, LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.

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