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Assoc Dir, Global Biosimilar Clinical Operations
4 months ago
Who are we?Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growthJob DescriptionThis position requires 2-3 days in the West Chester, PA Facility
The Associate Director, Global Clinical Operations, within Biosimilar operations team is responsible to lead and oversee the operational execution of Teva’s clinical studies from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring patient safety and data quality and integrity.
Travel Requirements: Must be able to travel with overnight stays, as necessary, travel up to 20%Essential Duties & Responsibilities:Lead the development of the operational plans for clinical deliverables for assigned complex and/or multiple studies in parallel, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP).Ensure operational plans and activities are in line within the assigned studies.Collaborate with CQA to establish an auditing plan for assigned studies to ensure timely resolution of CQA audit findings at the global study or program level and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable).Accountable for the performance and results of global studies, including:May provide direct management, career development and training of Clinical Study Managers (CSMs) and other GCO staff responsible for the timely execution of high quality clinical studies within budget and according to SOPs.Foster a collaborative, innovative, problems-solving culture with cross-functional team members for timely and high quality execution of studies. Review and approve clinical outsourcing specifications.Manage the CROs, vendors and consultants, working closely with Procurement for performance and quality metrics.Conduct and/or ensure completion of all oversight activities (e.g. oversight site visits, monitoring report review) as per the study vendor management plan.Prepare recruitment projections and select countries and sites in collaboration with the study team and CRO.Ensure compliance with Quality standards (SOPs, GCP, etc.).Ensure that all essential documents are present and that the TMF is complete prior to transfer to Teva. Ensures a summary of the CSR is distributed to the relevant parties.Qualifications Education Required: BA/BS degree (preferred Graduate/MSc degree) in applicable discipline Experience Required: At least 7 years of experience pharmaceutical industry or clinical research site based experienceKnowledge of ICH GCP guidelines Computer literate Fluent in English Experience Preferred: Global clinical trial management experience preferredMonitoring experience preferred Oncology TA experience preferredFunctionResearch & DevelopmentSub FunctionClinical DevelopmentReports ToIn process of validationAlready Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site 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.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
