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Manager, Pharmacokinetics

Manager, Pharmacokinetics

PadagisLiberty Township, OH, United States
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Description

The Manager, Pharmacokinetics will be responsible for overseeing and managing pharmacokinetic (PK) studies in support of drug development programs within a generic and 505b2 pharmaceutical organization. This role requires a combination of technical expertise and leadership to ensure the successful planning, execution, and interpretation of PK studies. The individual will play a crucial role in regulatory submissions, ensuring alignment with global regulatory guidelines and compliance with company standards. The role involves working in a fast-paced, deadline-driven atmosphere with cross-functional teams.

Job duties :

Pharmacokinetic Study Design and Oversight :

  • Design, plan, and oversee pharmacokinetic and bioequivalence studies from early clinical development to regulatory submission.
  • Collaborate with cross-functional teams, including clinical, regulatory, and project management teams, to align study designs with overall program objectives.
  • Provide scientific expertise and guidance for defining study parameters, data collection, and interpretation.

Regulatory Compliance and Documentation :

  • Ensure all PK studies meet global regulatory standards (e.g., FDA, EMA, ICH, etc.).
  • Prepare, review, and contribute to regulatory submissions, including ANDA, NDA, and 505(b)(2) applications.
  • Respond to regulatory queries concerning pharmacokinetics and bioequivalence data.
  • Data Analysis and Interpretation :

  • Analyze and interpret pharmacokinetic data using appropriate modeling and simulation tools (e.g., WinNonlin, NONMEM).
  • Assess drug absorption, distribution, metabolism, and excretion (ADME) profiles to support clinical development and product approvals.
  • Summarize and present scientific findings to both internal and external stakeholders.
  • Leadership and Collaboration :

  • Lead and mentor a team of pharmacokinetic scientists and analysts, fostering an environment of collaboration and scientific excellence.
  • Collaborate with external clinical research organizations (CROs) to ensure the timely and successful completion of PK studies.
  • Provide technical input for business development opportunities and pipeline expansion projects.
  • Continuous Improvement :

  • Stay abreast of the latest advancements in pharmacokinetics, bioequivalence guidelines, and regulatory requirements.
  • Implement best practices to improve the efficiency, quality, and scientific rigor of PK studies and data analysis.
  • Minimum qualifications :

  • Master's degree in Pharmacokinetics, Pharmaceutical Sciences, Clinical Pharmacology, or a related discipline is required.
  • Five or more (5+) years of experience managing pharmacokinetic studies in a pharmaceutical or biotechnology setting.
  • Proven track record of successful contributions to regulatory submissions and approvals.
  • Proficiency in PK and statistical modeling tools such as WinNonlin, NONMEM, and other relevant software.
  • Strong leadership and interpersonal skills to manage teams and collaborate effectively.
  • Excellent written and verbal communication skills for scientific and regulatory documentation.
  • Attention to detail and the ability to manage multiple projects with competing deadlines.
  • Strong understanding of bioequivalence requirements and regulatory expectations in the generic drug industry.
  • Preferred qualifications :

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Clinical Pharmacology, or a related discipline
  • Experience in generic pharmaceuticals
  • Padagis Core Competencies :

    Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five "core" competencies. We strive to bring employees on board the journey with us who exemplify these key competencies :

  • Service delivery - Understand who your internal and external customers are, identify their needs, and deliver value above their expectations...
  • Active collaboration - Seek opportunities to work together across teams, function, business units, and geographies to seek success...
  • Demonstrate agility - Proactively identify changes in our environment and act quickly, leading or embracing change...
  • Think differently - Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists...
  • Excellent execution - Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes...
  • About us :

    At Padagis our focus is on health care products that improve people's lives. We are a market-leading generic prescription pharmaceutical company that specializes in "extended topical" medications, like creams, foams, mousses, gels, liquids and inhalable products. It's a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We've already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

    What's Next :

    At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.

    Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

    This employer is required to notify all applicants of their rights pursuant to federal employment laws.

    For further information, please review the Know Your Rights notice from the Department of Labor.

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    Manager • Liberty Township, OH, United States

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