Vice-President, Clinical Operations
Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html
The successful candidate will supervise all of the Clinical Study Teams (CSTs) to achieve clinical study deliverables, working with in-house and CRO program managers and clinical research associates. S/He will oversee program level execution of all Clinical Development drug candidates in all phases of development to achieve the target goals for each program.
- Supervise senior clinical operations staff to achieve all milestones and deliverables of all company sponsored studies (from protocol creation time lines to final clinical study report sign off) including study initiation on time, achieve enrolment targets, maintain high quality of study data, data cleaning, database lock, and clinical study report drafting and finalization).
- Track deliverables and progress of investigator initiated studies. The candidate will be responsible for the successful operations of all study teams to achieve the study objectives at the highest standards and on time and budget.. All tasks and activities will be conducted full compliance with regulatory requirements, GCP, good medical practice, and applicable SOP’s.
- Supervise all study activities, with the CST team members in terms of study initiation, the data collection activities, and site management. Monitors adherence to protocols and study timelines.
- Identifies program risks; proactively creates and implements mitigation strategies. Provide Sr. Management with necessary reports on progress and changes in scope, schedule and resources in a timely manner including preparation of presentations and documents to the R&D Strategy Committee (RDSC)
- Works with internal team members in the development and implementation of compliance programs for Clinical Trials, including SOP’s.
- Manage high performing teams of Clinical Program Managers to achieve their goals and objectives as it relates to the different clinical studies objectives. Must be able to manage and develop people
- Develop relationships with key thought leaders to support product development, he or she will represent Astex externally in applicable scientific and medical forums. Performs job duties with minimal guidance and has sound critical thinking and problem solving skills.
- Prior experience managing oncology and/or trials is a must.
- Knowledge of Key Opinion Leaders in the areas of oncology/hematology highly desired.
- A minimum of 10 years managing clinical operation/development in a pharmaceutical and/or biotechnology company, demonstrating a broad background in those environments.
- Ability to manage the needs of multiple internal and external partners and deploy resources to meet those needs.
- Able to multitask and supervise a broad portfolio of drugs all in different phases of development.
- Must have managed multiple global studies (at minimum in North America and Europe with large numbers of center in multiple countries.
- Familiar with recent trends in accelerating and streamlining clinical trials operations.
- Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials
- Familiar with data processing methods, general knowledge of clinical medicine, oncology, and medical terminology.
- Superb managerial and mentoring skills and the ability to interact with and train clinical monitors and physician investigators and build constructive, trusting and respectful relationships with people at all levels within and outside the organization.
- Excellent leadership, performance management, communication and organizational skills required.