Associate Director, Clinical Operations

The Celcuity Associate Director of Clinical Operations is responsible for initiating and leading clinical trials across all phases, including overseeing vendors. This position will work collaboratively and cross-functionally on clinical operations strategy and related initiatives to ensure successful execution of assigned projects.

JOB RESPONSIBILITIES:

Essential Job Functions and Responsibilities may include but are not limited to:

• Accountable for delivery of assigned clinical program/studies, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

• Partner and collaborate with cross-functional stakeholders such as the Clinical Lead and other relevant stakeholders

• Lead and oversee execution of Phase I through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and internal Celcuity, Inc. SOPs

• Support the selection, oversight, and management of CROs and other vendors

• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

• Along with other Clinical Operations/Clinical Development personnel, represent Celcuity externally to Investigators, site staff, and Key Opinion Leaders

• Perform and document study level Sponsor Oversight of outsourced clinical activities

• Communicate study-status, cost and issues to ensure timely decision-making by senior management

• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Celcuity

• Support program level deliverables/activities at the discretion of the Vice President of Clinical Operations

• Provide oversight and mentorship to assigned Clinical Trial Managers and other Clinical Operations team members by providing clinical operations and functional area expertise. May include direct management of junior clinical operations staff

• Strive for continuous improvement and more efficient ways of working in clinical development.

• Other duties as assigned.

COMPETENCIES:

To perform the job successfully, an individual should demonstrate the following competencies:

• Design - Generates creative solutions; Uses feedback to modify designs; applies design principles; Demonstrates attention to detail.

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions.

• Ethics - Works with integrity and ethically.

• Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas; presents ideas and information in a manner that gets others attention.

• Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; develops realistic action plans.

• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality.

EXPERIENCE:

Required:

• Minimum of BA/BS with at least 6 years of trial and clinical program experience. Advanced degree preferred.

• Experience in Oncology indications highly desired

• Solid experience in early and late phase drug development

• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

• Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

• Experience in GCP inspections/audits

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Resilient, Creative, capable problem-solver

• Excellent organizational skills and ability to work independently

• Experience in maintaining relationships with key opinion leaders

• Some travel required

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

Typical office environment. Prolonged periods of sitting at a desk and working on a

computer. Must be able to lift 15 lbs. at times.