Senior Director Clinical Operations

Posted 25 September 2022
Salary Salary Competitive
LocationUnited States of America
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameLewis Joshi

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