Director/Senior Director of Clinical Operations

Cambridge, MA, United States
Jan 10, 2021
Required Education
Bachelors Degree
Position Type
Full time
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.

Cue Biopharma is building a world-class team of highly motivated, dedicated scientists to help us advance our research and development programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.

Job Summary

The Director/Senior Director of Clinical Operations is a leadership role within Cue Biopharma's Translational Biology Group. It requires strategic oversight and accountability for the delivery of specific clinical development programs. The Director/Senior Director will provide leadership to all operations functions assigned to the implementation of a clinical project and represents clinical development functions as a core member of the cross-functional early development team. This position is responsible and accountable for all operational activities within a project and ensures these activities are performed according to quality, schedule and cost standards set by the Cue Biopharma executive leadership team, board of directors and standard operating procedure (SOP). Through appropriate leadership, direction and operational expertise, the Director/Senior Director will contribute to the clinical development strategies for specific projects and act as a key partner with internal and external stakeholders including translational medicine scientists and leaders, clinical pharmacologists, biomarker leaders, and project team leaders to ensure the effective implementation of the early clinical development strategy through deployment of internal and external resources. The Director/Senior Director of Clinical Operations will also have responsibility as the lead manager for specific external partners.

Candidate Profile

The successful candidate will have a strong scientific background and leadership experience in early clinical development. In addition, the successful candidate will have experience working on cross-functional teams coordinating and managing activities with external partners, clinical sites and investigators to initiate and conduct early phase oncology clinical trials. Attention to detail and commitment to excellence in the execution of a clinical trial and effective communication with internal and external stakeholders are essential.

Key Responsibilities
  • Ensuring internal and external alignment and timely execution of the CDP.
  • Accountable for the operational implementation of clinical development programs within timelines, budget and Cue Biopharma standards. These include trials from Entry into Human through Phase 2 studies as well as clinical pharmacology and experimental biomarker studies.
  • Membership of clinical team and biology project teams for one or more early development molecules, providing operational input to the definition of project strategy and feasibility of execution.
  • Accountable to the biology project team for timely and accurate forecasting and delivery of operations project resource and budget, for planning, tracking and managing the operational budget, resources (allocation) and timelines for the project against the agreed goals of the team.
  • Effective collaboration with the appropriate internal functions in defining the resourcing and the outsourcing strategy for the early development programs.
  • Ensure project implemented according to ethical/regulatory/legal requirements.
  • Accountable for the selection of vendors including the clinical CRO for pipeline projects entering Phase 1 trials, oversight of CRO activities and effective collaboration with CRO and clinical investigator team. These are intended to describe the general nature and level of the work.
  • Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.

  • University degree or equivalent preferably in a medical/science-related field.
  • A minimum of 4+ years of clinical trial experience and at least 2 years of experience managing a team comprised of a trial sponsor and clinical CRO.
  • The ability to lead people and translate strategies into actions for the team as well as provide focus and direction to successfully navigate through complexity and uncertainty. Strong interpersonal skills.
  • Excellent written and verbal communication skills demonstrated by an ability to present clear messages to internal and external stakeholders. Experience in preparing regulatory documents such as informed consent forms, protocols, and safety reports
  • Proven track record of effective decision-making and implementation of project plans including delivering on time and within budget.