Director / Senior Director, Head of Clinical Operations

Employer
Cue Biopharma
Location
Cambridge, MA
Posted
Jan 03, 2019
Required Education
High School or equivalent
Position Type
Full time

The Head of Clinical Operations (HCO) will have a leadership role with strategic oversight and accountability for delivery of specific clinical development programs within Cue Biopharma. The HCO is responsible and accountable for all operational activities within a project and represents Clinical Development functions as a core member of the cross functional early development team. Through appropriate leadership, direction and operational expertise, the HCO contributes to the clinical development strategies for specific Cue Biopharma projects. The HCO acts 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 HCO will also have responsibility as the lead manager for specific external partners. 

The successful applicant will have a strong scientific background and leadership experience in early clinical development. Preferred experience includes 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.​

Key Responsibilities:     

  • Strong scientific background and leadership experience in early (IND-enabling) and late-stage clinical development.

  •  Experience providing strategic input on the development of optimal clinical development plans (CDPs).

  • Track record ensuring internal and external alignment and timely execution of CDPs, while providing constructive and challenging risk management/business value assessment. 

  • Accountability for the operational implementation of clinical development programs within timelines, budget and standards (pre-clinical through Phase 2 studies, clinical pharmacology and experimental biomarker studies). 

  • Timely and accurate forecasting and delivery of operations project resources and budget.

  • Effective internal collaboration to define resourcing and the outsourcing strategy for early development programs. 

  • Ability to assume leadership of project sub-teams. 

  • Project implementation experience according to ethical/regulatory/legal requirements. 

  • Clinical contract research organization (CRO) selection and activities oversight. 

Requirements:

  • University degree or equivalent, preferably in a medical/science-related field.

  • Four or more years of clinical trial experience, with at least two years of experience in clinical trial management on the sponsor side is strongly desirable.

  • Exceptional interpersonal and leadership skills. Demonstrated ability to translate strategies into actions for the team and to provide focus and direction to successfully navigate through complexity and uncertainty. 

  • Excellent written and verbal communication skills demonstrated by an ability to present clear messages to internal and external stakeholders.

  • Proven track record of effective decision-making and proven experience of implementation of project plans delivering on time and within budget