Teva Director Clinical Start-Up Lead West Chester PA 

United States, Pennsylvania, East Bradford Township 

176560449

As theyou will play a pivotal role within the Global Clinial Opertions (GCO) Trial Optimization, Planning, and Start-Up (TOPS) management team, spearheading strategic and timely site start-up initiatives. You will lead efforts to achieve transformative efficiencies in site activation while delivering exceptional outcomes for global clinical programs across all therapeutic areas and phases.

• Drive Site Start-Up Excellence: Accountable for delivering site start-up activities from feasibility to activation, ensuring compliance with GCP, regulatory requirements, and the Clinical Development Plan (CDP).
• Strategic Partnerships: Collaborate with external partners, internal stakeholders, KOLs, and investigative sites to accelerate and optimize site start-up and activation.
• Resource Management: Forecast and allocate Start-Up resources effectively to align with project demands.
• Process Improvement: Track and report key metrics, including cycle times, to identify opportunities for accelerating site activation and enhancing efficiency.
• Best Practices Development: Build and maintain best practices for study start-up, country, and site activation processes, ensuring alignment with clinical development strategies.
• Operational Leadership: Lead the Start-Up Group (SUG) by defining career development plans, fostering a collaborative and high-performance culture, and overseeing CROs, vendors, and consultants.
• Protocol Review and Input: Provide strategic input on clinical study protocols to ensure feasibility and alignment with site and organizational capabilities.
• Risk Management and Communication: Identify risks, develop mitigation plans, and ensure effective communication of progress, KPIs, and escalations to senior management.

• Educational Background: BA degree required; Graduate/MSc degree in an applicable discipline preferred.
• Experience: 10+ years of related experience with progressive leadership roles in global clinical operations, showcasing a strong track record of strategic decision-making and organizational impact.
• Leadership Excellence: Demonstrated success in leading large, matrixed teams and driving global initiatives, coupled with proven ability to motivate, inspire, and develop team members to reach their full potential.
• Technical Expertise: Extensive knowledge of GCP, ICH guidelines, and clinical trial operations across multiple phases and therapeutic areas, supported by vendor and CRO management experience.
• Strategic Vision: Proven ability to provide clinical strategic and operational expertise, fostering innovation and applying strategic thinking to achieve success.
• Process Optimization: Strong experience in process improvement, design, project management, and budget oversight, with a focus on operational excellence.
• Technological Proficiency: Adept in Information Technologies with the ability to leverage tools effectively in clinical operations.
• Communication Skills: Exceptional presentation and communication abilities to clearly convey complex concepts to a wide range of internal and external professionals.
• Multitasking and Organization: Skilled in managing multiple projects simultaneously, meeting tight deadlines while maintaining high-quality standards.
• Global Collaboration: Proven ability to interface professionally and influence diverse stakeholders, including internal teams, external partners, and key opinion leaders.
• Clinical Expertise: Comprehensive knowledge and hands-on experience in clinical trial methodologies, best practices, and therapeutic areas.

West Chester, PA

This is a hybrid role, and you will required to work on-site 3days/ week.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 12 paid Holidays and 1 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.