Manager, Pharmacokinetics

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.