Director Clinical Operations-Insperity
ONCOtherapeutics is a CRO (clinical research organization) located in West Hollywood, California. We are a strategic CRO running multiple clinical trials in community and academic oncology sites throughout the United States (US). We provide necessary support to major biopharmaceutical companies throughout the US to successfully run, enroll and complete clinical trials. Uniquely including mostly community-based Hematology & Oncology research sites, we provide real-world experience, data and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients.
Director, Clinical Operations
ONCOtherapeutics is actively recruiting for a Director of Clinical Operations, accountable for the resourcing, development, training and management of a successful clinical operations team.
Your essential responsibilities as the Director, Clinical Operations will include:
- Create, execute and proactively manage clinical trial processes.
- Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met.
- Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines
- Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols at ONCOtherapeutics; interact and collaborate with other department heads as appropriate.
- Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders.
- Lead & mentor Clinical Operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff.
- Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards
- Mentor Clinical Operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness
- Assist in the development, review and updating of ONCOtherapeutics clinical SOPs
- Accountable for development, authorization, signing of operational documents (such as contracts, budgets, etc.) and leading the identification of and interaction with investigative sites and investigators, including study execution.
- Identify, develop and maintain strong relationships with trial sites, external experts and Investigators to ensure effective execution of internal and external clinical projects.
- Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies.
- Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans
- Help to expand business opportunities by helping to define, develop and nurture key partner relationships
- Help to identify trendsetter ideas by staying abreast of industry and related events, publications, and announcements
- Develops engagement strategies and positions by understanding target company dynamics and product development plans to optimize collaboration potential
- Facilitates new business deals by coordinating requirements, developing and negotiating contracts and integrating contract requirements with business operations
You should have:
- Bachelors in Life Sciences, or Pharmacy; an advanced degree (MD, MS, MBA and/or PharmD) is preferred.
- A minimum of 5 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing and leading early to late stage clinical trials.
- In-depth understanding and experience across the clinical operations value chain with a track record of success in study planning, execution, data cleaning, database locking, study report generation, and regulatory inspection. Therapeutic experience in Hematology/Oncology coupled with experience with pivotal, multi-site clinical trials is highly desirable.
- Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
- Experience with clinical data management is a plus.
- Expertise in clinical operations – demonstrated ability to effectively manage projects and people. Proactive problem-solving abilities and follow-through
- Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization
- Experience leading a rapidly changing organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems
- Must have a thorough knowledge of clinical research concepts, practices and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design and data management methods. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
- For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues
Work Environment:
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically on occasion is required. Work will be on site unless otherwise permission is granted to work off site by the President or COO.
Benefits:
We value our employees’ time and efforts. Our commitment to your success is enhanced by our extensive benefits package and salary ($150K, plus bonus ) including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.