Job Description:

PositionVice President, Clinical OperationsReporting to the CMO, the Vice President, Clinical Operations, will lead global clinical operations. The role will be responsible for planning and executing clinical trials initially in the US, and later in Europe and other countries worldwide, within time and cost constraints, ultimately resulting in high quality clinical trial data on all investigational products and marketed medicines.S/he will influence decision making and strategy for the Company, requiring expertise in compliance, assessment, and leadership spanning the support of existing and potential partnerships.The ideal candidate will be a strong, collaborative leader who brings a tactile and strategic approach to projects spanning the clinical development process.ResponsibilitiesJob Responsibilities include, but are not limited to:Hire, lead, and manage a team of highly experienced clinical operations professionals, both external consultants and internal employeesDeliver consistently high-quality results that are on time and within budget guidelines for all clinical studies, across the product lifecycle (phase 1 through phase 4)Accountable for vendor managemento Ensure requests for proposals (RFPs) meet user requirements, and all contracts (i.e., study sites, vendors) are efficiently executed with key performance indicators o Partner with finance team to accurately estimate trial costs to enable the long-range planning process, and ensure teams accurately accrue costs throughout duration of clinical trials o Lead all vendor governance committeesCreate, manage, and execute clinical operations and development programs, including study management, budget and timeline creation.Oversee cross-functional authorship of key study related documents: protocol concept sheets, protocol synopses, protocols, informed consent forms, case report forms, study governance committee charters (e.g., data monitoring committee) and clinical study reportsAccountable for both in-house and outsourced data management and clinical study drug management (forecasting, labeling, packaging, and distribution activities)Responsible for the creation and maintenance of clinical trial recruitment dashboards to enable real-time understanding of progress and issue identification; proactively propose solutions to achieve goalsOwn the creation and maintenance of all clinical trial related systems, standard operating procedures (SOPs), and policiesResponsible for achieving annual departmental budget goalsPossesses an understanding of and experience in leading clinical development programs in oncologyBuild strong KOL and investigator relationships with the capability of understanding and explaining complex scientific topicsLiaise with clinical site staff and investigators as appropriate to ensure optimal sponsor-site relationshipsHelp to author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessaryDevelop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)Participate in preparation of regulatory filings (e.g. pre-IND, IND, orphan applications etc.) as neededManage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelinesManages and develops clinical operations quality systems, including standard operating procedures, document management, clinical operations personnel training, and quality control processesLead, plan, and execute clinical investigator meetings, study meetings, and vendor meetings as neededQualificationsAt least 15 years of experience in clinical trial operations across the product lifecycle (phase 1 healthy volunteer studies to post approval studies). Minimum of 3 years of experience leading a clinical operations department at a senior director or above level, with accountability for multiple, parallel clinical trials or development programsAdvanced degree in scientific field such as PhD, PharmD, MS preferredDomain expertise in oncology drug development is requiredKnown to be a clinical operations expert, with a prior track record of innovative trial execution that utilizes the latest technologies to ease site and study participant burden, decrease cost, maintain data integrity plus participant retention and achieve health authority requirementsWell established career path including having built a clinical operations department and collaborated extensively with other functional departments: research, clinical research, regulatory affairs, medical affairsA seasoned leader, manager and mentor of FTEs and consultantsSuccessful experience in at least one fast-paced entrepreneurial biotechnology environmentStrong working knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trialsExcellent written and verbal communication skillsStrong analytical and strategic planning skillsProven ability to provide scientific and clinical expertise to a clinical development programStrong leadership skills; communicates and demonstrates vision and commitment.Demonstrates effective influence and relationship management skills.Must display strong analytical, problem-solving skills and attention to detailSelf-starter, independent and a practical thinker