Careers
Director, Clinical Operations (DCO-412)
Ambit Biosciences is a privately-held biopharmaceutical company engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit Biosciences has the technology, the expertise and the vision to succeed in the kinase space. We are seeking a talented Director, Clinical Operations.
The Director, Clinical Operations will manage, direct and further develop the clinical operations function, maintaining a highly capable organization that excels in the planning and implementation of assigned clinical programs leading to commercialization of Ambit Biosciences proprietary products. The incumbent also ensures that administrative and operational policies and procedures are developed and maintained, serve as an internal consultant in areas of expertise, and is an active member of the Clinical Development team. Additionally, the incumbent will work closely with Regulatory Affairs, Research and Development, and Legal departments inside the company, as well as consultants, vendors, corporate partners, and other individuals outside the company to design, implement, and summarize clinical trials with a focus on worldwide registration and commercialization of Ambit Biosciences products.
Key responsibilities will include, but are not limited to:
- Helps lead and supervise the Ambit Clinical Operations Team
- Manages and oversees vendor / partner relationships and operations
- Participates in formulation of overall clinical strategy with senior management.
- Plans and implements clinical studies (Phase I - III) needed to establish the safety and effectiveness of new products major world markets.
- Coordinates data summarization, analysis, report writing of assigned clinical studies/programs in a manner consistent with achievement of corporate objectives.
- Interacts with worldwide regulatory agencies, as necessary. Prepares and maintains appropriate documents for assigned clinical programs, including protocols, protocol amendments, investigator's brochures, case report forms, specific clinical IND and NDA/MAA submissions.
- Actively participates in clinical study site selection, on-site clinical monitoring (as necessary), and off-site administrative oversight to ensure an investigator's compliance with study protocol, regulatory guidelines, and Company SOPs.
- Identifies, develops, and maintains appropriate processes and Standard Operating Procedures (SOPs) for area of responsibility.
- Communicates and interacts effectively with in-house personnel and clinical investigative sites.
- Manages clinical budgets and clinical study agreements for assigned programs.
- Managing career development of clinical development team
- Assists in preparation of scientific papers and presentations, as necessary.
Knowledge, Skills, Experience, and Education Required:
- Bachelors Degree (Master's degree preferred) and minimum 10 years experience managing pharmaceutical clinical development/research operations. Oncology experience essential.
- Demonstrated managerial, organizational, and leadership skills in a dynamic environment running multiple clinical trials.
- Demonstrated experience focused on clinical investigation, clinical operations, drug safety reporting.
- Strong working knowledge of US and international regulatory requirements and excellent knowledge of ICH/FDA guidelines. Excellent planning, organizing and execution skills. Must be results driven.
- Strong interpersonal skills and has a leadership style that provides timely coaching, guidance and feedback to assist others in their individual or group performance
- Travel up to 20% to clinical study sites and meeting