Mantell Associates is currently partnered with a Biopharmaceutical organisation in their search for a Senior Director of Clinical Operations.
Senior Director of Clinical Operations - Responsibilities:
Manage vendor relationships and develop ideal outsourcing model for delivery on clinical portfolio, such as oversight of CROs and other vendors
Spearhead strategic planning and the implementation of all clinical development programs globally
Develop, maintain, and report on program budgets, such as long-range forecasting and monthly accruals
Build process for and oversee medical writing, including contributing to and authoring documents such as study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and sections of regulatory submission documents
Create and maintain appropriate standard operating procedures (SOPs) and compliant management of clinical records
Create and lead a team of internal and external multifunctional stakeholders with a focus on programme management and study execution; assess and create the optimum outsourcing model for clinical portfolio delivery, including control over CROs and other vendors/external partners
Create and maintain strong connections with researchers, key opinion leaders (KOLs), patient advocacy organisations, and regulatory bodies to implement study procedures, provide comments, etc.
Work efficiently in collaboration with key subject matter experts in data management, safety/pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs.
Senior Director of Clinical Operations -Requirements:
Strong industry experience in all phases of clinical development, with leadership experience in domestic and foreign studies throughout all stages of clinical development
Degree in business, science or a related discipline
Experience in managing vendors
Strong clinical operational experience for either a biotech or pharmaceutical company
Demonstrated expertise in CRO/vendor selection and management, forecasting and managing budgets, setting up specific deadlines, assuring the delivery of high-quality data, and producing reports
A thorough working understanding of all pertinent regulations, such as those established by local international regulatory authorities as well as the ICH, GCP, and FDA
In-depth knowledge of the cross-functional procedures used in research planning and execution, such as protocol preparation, data management, safety/pharmacovigilance, biostatistics, medical writing, quality assurance, and regulatory- and medical- issues
Proven competence in managing project and portfolio priorities, as well as strong interpersonal, analytical, and organisational abilities
The capacity to lead strategic discussions, inspire and influence others, foster a team-oriented environment, and interact with key internal and external stakeholders, such as the leadership team, principal investigators, key opinion leaders (KOLs), CRO partners, patient advocacy organisations, and regulatory agencies
Expertise in the implementation and use of clinical database software/TMS, as well as other pertinent applications such the Microsoft Office Suite
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.