Director Clinical Operations Program Leader – Hematology – is a senior member of the Clinical Operations team. This position is primarily a Strategic role, reporting into the Sr. Director (or above) responsible for Operational Program/Study Strategy and delivery within the Hematology Liquid tumor space. The highly experienced Director – Development Clinical Operations will be responsible for the Ops management of multiple programs in different stages of development.
Providing strategic input to the development of an optimal Clinical Development Plan and providing constructive and challenging critique (risk management/business value assessment).
Accountable to the GPT for the operational implementation of Therapeutic area clinical development programs within agreed timelines, budget and company standards. These include trials from Entry Into Human through phase III as well as clinical pharmacology and experimental medicine studies.
Interface with Senior Director to ensure planning & decision-making on study placement is in line with the sourcing strategy.
Providing operational input to the definition of project strategy and robust feasibility of execution.
Accountable for timely and accurate forecasting and delivery of operations project resource and budget
Accountable for planning, tracking and managing the operational budget, resources (allocation) and timelines for the project against the agreed goals of the team
Collaborating with the appropriate Functions in defining the resourcing and the outsourcing strategy for the early development programs
Provide input to Senior Director in case of project prioritization exercises within the Therapeutic Area portfolio
May participate in Business Development/ in-licensing assessments
May be required to assume leadership of project sub-teams e.g. Clinical Team
Ensure all programs under their remit are implemented according to ethical/regulatory/legal requirement.
Accountable for the selection of the CRO.
Contribute to the functional excellence efforts and initiatives in Operations and at Clinical Development level as requested.
May line manage Associate Directors, Senior Study Managers, Study Managers and Study Associates including responsibility for staff recruitment, development, coaching, mentoring and performance management.
Work to develop resourcing strategy with Senior Director and may be responsible to Hire Staff for both Full-Time Positions and/or Contract position
Support the training and mentoring for new staff and/or temporary contractors
A minimum of BS or completion of a Nursing Program (RN) is required. Advanced degrees are preferred.
A minimum of 10 years of clinical research/clinical trial experience within the Pharmaceutical, Clinical Research Organization (CRO) and/or Biotech industries working in Clinical Operations Oncology/Hematology (pre NDA work or supporting NDA clinical trials Or New IND) (Medical Affairs Experience will not be considered)
At least 5 years in leading clinical operations teams in Hematology patient studies in development (not medical affairs)
. (IRR & ISS studies will not be considered).
At least 2 years in Early Development Oncology PATIENT Studies and Clinical Pharmacology is preferred.
At least 2 years in Early Development Oncology Patient studies working with sample management.
Previous experience leading an Oncology Patient study from start to finish which supported an NDA filing is preferred.
Previous demonstrated experience working with CROs working on oncology clinical operations patient studies.
Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), and local regulatory requirements required.
Experience working with computer software applications required. Experience with clinical systems preferred.
This position will require up to 20% travel.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please ****.
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