Job description
Mantell Associates are partnered with one of the most unique, exciting and rapidly growing Biotech's in their search for a Senior Director of Clinical Operations based in Boston.
Are you looking for a massive step up in your career to join an organisation that will have you reporting to C-Suite level individuals.
Are you tired of not having your ideas heard, respected, and implemented?
This is the opportunity for you!
Director/Senior Director Clinical Operations Responsibilities:
Ensure that clinical-stage antibody projects are on pace to meet relevant goals and milestones while delivering within agreed-upon deadlines, budgets, and quality standards, including compliance with all relevant laws and regulations.
Oversee the strategic planning and execution of all clinical research programmes being implemented internationally, including study start-up, operations, execution, risk assessment and mitigation, completion, and reporting.
Create, monitor, and report on programme budgets that support the monetary objectives of Compass, including long-term forecasts and monthly accruals.
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.
Establish a process for medical writing and manage it, including authoring and contributing to documents like informed consent forms (ICFs), clinical study reports (CSRs), and sections of regulatory submission documents; develop and uphold suitable standard operating procedures (SOPs), and manage clinical records in compliance.
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.
Maintain and develop an inventive, cooperative, and inspiring culture.
May involve both regional, national and international travel.
Director/Senior Director Clinical Operations Requirements:
10+ years of experience in the industry, with at least 5 years of leadership experience in domestic and foreign studies throughout all stages of clinical development; 2–5 years in a supervisory capacity.
A graduate degree in business or science is necessary.
Extensive expertise in managing drug research and development programmes, from IND- to BLA; and understanding of how to prepare clinical sections for INDs, BLAs, and MAAs.
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.
Strong written and verbal business communication abilities.
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 Lewis Joshi on +44 20 38 54 7718 or lewis.joshi@mantellassociates.com.