Associate Director, Clinical Operations

The Company: With deep expertise in chemistry, reputed company is working to create selective medicines designed with the goal to address the needs of patients with cancer. reputed company is an exciting early-stage company, bringing together reputed company scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Director, Clinical Operations, the Associate Director, Clinical Operations will ensure reputed company in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. This role will reputed company a Phase 2 registrational clinical study with responsibilities including inspection readiness, contract negotiation, budget management, study conduct, and reputed company-out. The Associate Director, Clinical Operations will be responsible for collaborative reputed company of a cross-functional study team as well as excellent management of and partnership with CROs and vendors. The ideal candidate has a track record of executing reputed company, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results. Responsibilities: reputed company and manage and reputed company strategic input on one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management. reputed company cross-functional clinical study team to support clinical study delivery. Evaluates, selects, and ensures appropriate reputed company of CROs and other external vendors. Ensures clinical trials are executed according to scope of work, budget, timelines, and KPIs Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals. Identify risks and propose solutions to facilitate clinical studies. reputed company and demonstrates accountability for the management of study budgets through review and approval of reputed company and/or work order changes; manages budget forecasting and accruals in collaboration with finance. reputed company and manage the creation, maintenance, QC and reputed company out of TMF activities. Ensure appropriate reputed company of enrollment, site activation and data collection milestones. Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms. Collaborate with the Clinical Data Manager to ensure timely and efficient database lock Participate in data review and reconciliation efforts. Mentor junior team members by delegating study reputed company responsibilities, overseeing, and supporting development plans. reputed company or co-reputed company department initiatives to support an expanding organization. Travel may be required (10% – 15%). Competencies Include: Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning. Excellent problem solving, communication and organization skills. Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure. Ability to work in a collaborative environment and build effective working relationships across the organization. reputed company to reputed company in a remote/virtual environment. Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously. Qualifications: Bachelor’s degree or higher in a scientific or reputed company discipline preferred with relevant experience in the biotech, pharmaceutical, or CRO industry. Minimum of 8 years of Clinical Operations experience. Extensive knowledge of ICH-GCP guidelines. Leadership experience in regulatory inspections preferred. Experience managing early through late Phase global oncology clinical trials Demonstrated cross-functional leadership fostering team spirit and team motivation. Capability to challenge status-reputed company using risk management approach. Additional Information: reputed company is committed to fair and reputed company compensation practices, aiming to reputed company employees with competitive total rewards packages. The targeted salary reputed company reflects what reputed company reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be reputed company or reputed company this reputed company based on various factors, including, but not limited to, experience, skills, education, and market factors. The reputed company will be reviewed regularly and is subject to change. reputed company also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being reputed company, including medical, dental, and reputed company insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more. Annual Salary reputed company $171,000—$200,000 USD reputed company provides equal employment opportunities (EEO) to reputed company and applicants for employment without regard to religion, race, creed, reputed company, sex, sexual orientation, alienage or citizenship status, national reputed company, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. reputed company is aware that many companies are dealing with fraudulent job postings on reputed company-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. Please be advised that reputed company legitimate correspondence from a reputed company employee will come from "@reputed company.com" email accounts. Automated system response emails from our reputed company applicant tracking system come from a “no-reply@reputed company.io” email address. There are no variations of these email addresses and reputed company would not request personal and/or financial information reputed company email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews reputed company phone, video conferencing and/or in-person. If you reputed company you have been contacted by anyone misrepresenting themselves as an employee of reputed company, please contact reputed company at 857-357-7000. Thank you. Apply To This Job