Associate Director Operation Excellence & Project Management
Your tasks and responsibilities
- Leads all planning and execution activities in support of all assigned clinical and preclinical studies within the Medical Affairs Oncology SBU data generation program (IIR/RWE), expanded access programs and thought leader engagements.
Lead/Manage Study Activities
- Manages all aspects from receipt of concepts in the online portal, through review, contracting, payments, drug supply, management of ongoing studies and completion/deliverable;
- Collaborates with country affiliates and Medical Experts as appropriate to coordinates activities and ensure timely activation and follow-up on status of new and on-going studies;
- Interface with sponsor on start-up activities, study progress, payments/study medication shipments, study issues/timelines, and deliverables;
- Organize and contribute to the global multidisciplinary Review team (e.g. GISC) to ensure all functions align on the study design, timelines, budget, quality standards and operational procedures;
- Participate in MA Oncology dashboard reviews including management and execution of programs global strategy, and key clinical interest targets;
- Responsible for fair market value assessment of study budgets;
- Initiate and manage contracting process;
- Manage study medication forecasting, distribution, tracking, and issue resolution; liaise with Clinical Supplies Management for drug supply planning;
- Organize and contribute to cross functional protocol review meetings; provide feedback to investigator;
- Drives timelines for assigned programs/studies;
- Assess risks and obstacles to study performance and provides options for resolution;
- Interfaces with sponsor/study site/appropriate internal functions to handle and resolve operational and clinical issues;
- Ensures internal project-related activities and/or interactions with study sponsors comply with applicable guidelines and regulations governing externally sponsored studies;
- Develop and maintain medical knowledge, critical market insight, and industry awareness to support decision making.
Tracking and Reporting
- Owner and responsible for all systems and tracking tools for data generation programs; monitor to ensure content complete and accurate (e.g., drug supply tracker, budget tracker, IIR/RWE tracker, electronic submission system, IMPACT);
- Responsible for timely updates in specified database systems and trackers;
- Measures study performance using appropriate systems, tools, and techniques;
- Ensure accuracy of system generated reports on study metrics.
Manage External Vendors
- Develop Medical Affairs outsourcing specifications with respective line functions to facilitate bid templates and selection of CROs (when appropriate);
- Oversee and direct any activities outsourced to CROs and/or vendors;
- Facilitate SOW and contract activities for study related vendor services.
Preparation of Documents
- Contribute to development of drug handling instructions and protocol modules for assigned compounds;
- Coordinate periodic review by cross functional team of existing documents for updates.
Plan and Track Budgets
- Responsible for assessment of study and vendor budgets, milestone development, forecasting and tracking expenditure for assigned studies working closely with sponsors/vendors team, and controlling;
- Responsible to project and track drugs supply costs and communicate estimates with team and controlling;
- Accountable for providing quarterly budget estimate updates on assigned studies to team and controlling;
- Communicate variances in the budget.
Thought Leader Engagements
- Develop effective working relationships with Thought Leaders;
- Support TL interactions at congresses.
- Develop and maintain medical knowledge, critical market insight, and industry awareness to support decision making;
- Leads direct reports/junior colleagues in support of assigned projects (if applicable);
- Contributes to group, departmental and/or organizational process improvement initiatives;
- Provides project management excellence for successful outcomes in data generation programs that advance scientific knowledge for the betterment of therapies for oncology patients.
Who you are
Qualification & Competencies:
- Minimum of a Bachelor's degree is required (life sciences preferred);
- Bachelor’s degree with a minimum of 7 years clinical research experience (experience in clinical trial management and operations within the pharmaceutical industry or medical center setting);
- Master’s degree with a minimum 4 years clinical research experience;
- A minimum of 4 years in Pharmaceutical or Biopharmaceutical Industry required;
- A minimum of 3 years oncology experience required;
- Strong written, computer, and communication skills are necessary for success;
- Demonstrated understanding of ICH/GCP and US/EU regulations governing clinical trials;
- A high degree of responsibility and accountability providing high quality, compliant service to all internal and external customers are necessary for success.
- Master’s degree preferred.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Functional Area: [sap_fa_30]
Entry Level: 5