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.”
Equal Employment Opportunity and Affirmative Action. Allucent (US) 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. Allucent (US) 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.