Director, PK Bioanalytics
Teva Pharmaceuticals
6 months ago
On-site
West Chester, PA
Clinical Research and Development
Job Responsibilities:
- Lead a team of 10–15 people, set and monitor goals, address performance challenges, and oversee hiring and onboarding.
- Develop PK method strategies for complex biologics (e.g., bispecific, fusion molecules) to ensure “fit for purpose.”
- Represent the PK group and collaborate with Critical Regent, Non-Clinical, Clinical Pharmacology, Clinical Pharmacometrics, Biomarker, and Immunogenicity Assessment groups to align strategies.
- Ensure compliance with global regulatory standards (ICH, GCP, GLP); contribute to regulatory filings (IND, BLA, MAA); interact with Regulatory Agencies during meetings, teleconferences, and inspections.
- Serve as a single point of contact for specific projects in Non-Clinical and Clinical development meetings.
- Propose improvements to enhance robustness, quality, and efficiency with Lab Operations, Compliance & Quality, and Automation & Quality Assurance.
- Ensure timely, high-quality data delivery within budget.
Qualifications:
- Master’s degree in Biochemistry, Pharmacology, or related field plus 15+ years relevant experience; OR PhD plus 12+ years relevant experience in biopharmaceutical industry.
- 5+ years leading a group of 10+ bioanalytical scientists.
Skills/Knowledge:
- Proven experience in organizational growth, change leadership, and directing high-functioning bioanalytical science teams.
- Familiarity with LIMS and regulatory guidelines (FDA, EMA).
- Strong leadership, project management, problem-solving, communication, and presentation skills.
- System validation and automation (AI/ML) familiarity is a plus.
Travel Requirements:
- Occasional domestic/international travel as business needs arise.
Benefits (as stated):
- Comprehensive health insurance (medical, dental, vision, prescription) starting first day if enrolled; 401(k) with employer match (up to 6%) plus annual defined contribution (3.75%); Paid Time Off; company-paid life and disability insurance; additional listed benefits including EAP, ESPP, tuition assistance, FSA/HSA, volunteer time off, paid parental leave (if eligible), and others.
- Total compensation may include restricted stock units and discretionary awards (depending on role).
Application Instructions:
- Apply through Teva’s internal career site on Twist.
- Lead a team of 10–15 people, set and monitor goals, address performance challenges, and oversee hiring and onboarding.
- Develop PK method strategies for complex biologics (e.g., bispecific, fusion molecules) to ensure “fit for purpose.”
- Represent the PK group and collaborate with Critical Regent, Non-Clinical, Clinical Pharmacology, Clinical Pharmacometrics, Biomarker, and Immunogenicity Assessment groups to align strategies.
- Ensure compliance with global regulatory standards (ICH, GCP, GLP); contribute to regulatory filings (IND, BLA, MAA); interact with Regulatory Agencies during meetings, teleconferences, and inspections.
- Serve as a single point of contact for specific projects in Non-Clinical and Clinical development meetings.
- Propose improvements to enhance robustness, quality, and efficiency with Lab Operations, Compliance & Quality, and Automation & Quality Assurance.
- Ensure timely, high-quality data delivery within budget.
Qualifications:
- Master’s degree in Biochemistry, Pharmacology, or related field plus 15+ years relevant experience; OR PhD plus 12+ years relevant experience in biopharmaceutical industry.
- 5+ years leading a group of 10+ bioanalytical scientists.
Skills/Knowledge:
- Proven experience in organizational growth, change leadership, and directing high-functioning bioanalytical science teams.
- Familiarity with LIMS and regulatory guidelines (FDA, EMA).
- Strong leadership, project management, problem-solving, communication, and presentation skills.
- System validation and automation (AI/ML) familiarity is a plus.
Travel Requirements:
- Occasional domestic/international travel as business needs arise.
Benefits (as stated):
- Comprehensive health insurance (medical, dental, vision, prescription) starting first day if enrolled; 401(k) with employer match (up to 6%) plus annual defined contribution (3.75%); Paid Time Off; company-paid life and disability insurance; additional listed benefits including EAP, ESPP, tuition assistance, FSA/HSA, volunteer time off, paid parental leave (if eligible), and others.
- Total compensation may include restricted stock units and discretionary awards (depending on role).
Application Instructions:
- Apply through Teva’s internal career site on Twist.