Pharmacometrics and MIDD Director

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech™. Join us and build your future here.

What You'll Be Doing:

• Leads, coordinates, and oversees MIDD, PK, and PD support for Premier Research projects for both consulting projects and clinical studies being conducted by Premier Research and ensures that all MIDD, PK, and PD tasks meet expectations, and are delivered in accordance with the contract, ICH and FDA guidelines, and applicable SOPs
• Responsible for the actual analysis of PK, PD, and other relevant data using NCA, popPK, PK/PD relationships and takes the initiative to propagate best MIDD, PK, and PD practices and create SOPs to document these practices as needed
• Works within Regulatory Affairs, Medical Writing, Sponsors and project teams to provide MIDD, PK, and PD support and advice and to assure adequately communicated issues/problems and the possible solutions
• Drives MIDD, PK, and PD bids on opportunities to be sure the proposal describes realistic MIDD work with the Sponsor’s expectations and in line with the data endpoints and observations for analysis, modeling, and simulation being collected in the synopsis or protocol or in alignment with existing studies/data provided by the Sponsor
• Provides QC review of MIDD, PK, and PD input, model development, and output in conjunction with other team members and reviews and helps write protocols with PK and PD aspects
• Mentors other pharmacologists, pharmacokineticists, and biostatisticians on MIDD, PK, and PD methodology and trains staff on MIDD, PK, and PD aspects, as needed

What We Are Searching For:

• PhD or MS degree or its international equivalent in pharmacometrics, clinical pharmacology, or a pharmacokinetically related clinical, science or health related field from an accredited institution. PharmD with training in the above areas is also acceptable
• At least 10 years (MS and PharmD) or 7 years (PhD) of job-related MIDD, PK, and PD experience in the pharmaceutical industry beyond the PhD, MS, or PharmD degree
• Drug development support and pharmaceutical industry experience, including knowledge of ICH and local regulatory authority drug research and development regulations, preferred
• Hands-on experience coordinating, conducting, and overseeing MIDD projects, including but not limited to popPK, NCA, PK/PD relationships, and other cutting edge MIDD approaches
• Track record of expanding MIDD, PK, and PD-related offerings to clients and winning new business
• Up to date on MIDD efforts and approaches in the industry and regulatory agency acceptance of the various approaches to support client drug development projects

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $165,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

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Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status