Contact: Jim Sonnon
Phone: (267) 387-0090

Position Overview

Our client is a clinical-stage biotechnology company realizing the potential of peptide therapeutics. By connecting data and drug discovery through our computational technology platform, our approach was born from our early advances in anti-infectives, driving to find solutions for drug-resistant bacterial infections.

The Director / Senior Director Clinical Operations will assume a lead role in influencing the clinical operations strategy and execution of our client’s clinical program. This role works in close collaboration with the Development Team, as well as the CMO and SVP of Regulatory.

Job Responsibilities

Serve as the primary POC and lead for the operational management of clinical development programs.
Ensure successful completion of all clinical activities and project deliverables within the required time frame and budget.
Manage clinical trials both domestically and internationally via CROs and clinical vendors.
Complete internal and external clinical program documentation and reporting.
Identify, measure, and report on clinical program benchmark key performance indicators (KPIs) such as, but not exclusive to clinical synopsis development, finalization of clinical protocols, CRO contracting, patient screening, first patient enrolled, last patient enrolled, data lock, report finalization.
Meaningfully contribute to the planning and implementation of clinical development programs including scenario planning, timeline forecasting, program level feasibility assessments, estimation of resources and budget, and development of operational strategies.
Ensure all clinical programs meet or exceed applicable regulations and guidelines.
Work Safety – Ensures that all tasks and functions of position are performed in a safe manner at all times and that all procedures and requirements are properly followed to accomplish assigned tasks.
Other duties as assigned.

Job Requirements

BA/BS degree in related field required. RN/PA with professional clinical experience, and/or master’s degree or higher in health-related science or equivalent preferred.
10+ years of relevant Clinical Operations leadership experience.
Startup company clinical trial leadership preferred.
Depth of knowledge and experience managing Phase 1-4 pharmaceutical/biotech clinical trials both domestically and internationally via CROs and direct study management.
Demonstrated leadership skills related to managing directly, in a cross-functional matrix setting and interdepartmentally.
Strong track record of project management success on complex technology projects.
Ability to lead and to inspire cross-functional project teams towards a common goal.
Must have excellent interpersonal skills and be able to act with integrity and professionalism to ensure that all business is conducted without bias or prejudice.
Composure, positivity, flexibility, and time management ability necessary to succeed in a performance-driven environment.
Exceptional leadership, communication, operational, problem-solving, organizational and planning skills.
Ability to distill a reasonable solution with limited information and/or unclear guidance.
Ability to work well independently and without close supervision, keeping focused on short- and long-term objectives.
Ability to work within and to contribute to a group.
Must be very detail oriented and able to plan and prioritize a workload with competing priorities.
Ability to follow directions and meet deadlines.
Ability to handle confidential and sensitive information.
Mastery of project management software Microsoft Office Applications (Word, Excel, PowerPoint).

Location(s)

Remote

If interested, please send a MS Word version of your resume to [email protected]

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