What are the responsibilities and job description for the Associate Director Clinical Operations position at Bluejay Therapeutics?

Reporting to the Senior Vice President, Clinical Operations, the Associate Director, Clinical Operations will guide the clinical team to achieve all milestones and deliverables from protocol creation to study completion. The candidate will actively participate in developing and executing on the clinical trial strategy in support of the Clinical Development Plan, and to work across departments to ensure that studies are planned and conducted efficiently and with the highest quality. The Associate Director will manage cross-functional activities in order to ensure that clinical study goals are met on time and within budget. Onsite attendance is required 3 days a week.

PRIMARY RESPONSIBILITIES AND DUTIES :

Lead and oversee the execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and company objectives.
Develop and implement clinical strategies, study plans, and timelines for efficient trial execution.
Manage relationships with Contract Research Organizations (CROs), vendors, and investigative sites to optimize study performance.
Oversee site selection, feasibility assessments, and monitoring activities to ensure high-quality data collection and compliance.
Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Data Management, and Biostatistics.
Develop and manage study budgets, contracts, and timelines, ensuring cost-effective resource allocation.
Identify potential risks and develop mitigation strategies to address operational challenges.
Provide mentorship and leadership to clinical operations staff to foster professional growth and development.
Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and other relevant regulatory agencies.
Lead operational activities in preparation for regulatory submissions and inspections.

QUALIFICATIONS AND SKILLS :

Bachelor of Science degree with ten plus (10 ) years’ experience; MS / RN with eight plus (8 ) years’ experience.

Broad and deep knowledge of Clinical Operations, Data Management, Clinical Development, and Clinical Project Management.

Strong understanding of clinical trial design, execution, and regulatory requirements.

Proven ability to oversee and collaborate with CROs, vendors, and investigators.

Strong leadership and team management skills, with experience mentoring clinical operations staff.

Excellent problem-solving, organizational, and communication skills.

Ability to work in a fast-paced environment and manage multiple projects simultaneously.

Proficiency in clinical trial management systems (CTMS) and electronic trial master file (eTMF) systems.

Working knowledge of ICH / GCP guidelines.

Flexibility and willingness to adapt in a changing environment.

PHYSICAL DEMANDS :

Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.

The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.

Must be able to travel up to 10% of the time without restriction, domestically and / or internationally.

Ability to work at a computer for extensive periods of time.

Ability to work in a fast-paced working environment managing multiple tasks.

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS :

We offer benefits, and an environment where you will have the opportunity for personal and professional growth. BlueJay Therapeutics is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

ABOUT BlueJay Therapeutics Inc.

Bluejay is on a mission to illuminate a path toward treatment for serious viral and liver diseases starting with chronic hepatitis D and chronic hepatitis B.

SENIORITY LEVEL

Director

EMPLOYMENT TYPE

Full-time

JOB FUNCTION

Research, Analyst, and Information Technology

J-18808-Ljbffr

Apply for this job

Receive alerts for other Associate Director Clinical Operations job openings

Associate Director Clinical Operations

What are the responsibilities and job description for the Associate Director Clinical Operations position at Bluejay Therapeutics?

What is the career path for a Associate Director Clinical Operations?

Not the job you're looking for? Here are some other Associate Director Clinical Operations jobs in the Redwood, CA area that may be a better fit.

We don't have any other Associate Director Clinical Operations jobs in the Redwood, CA area right now.

AI Assistant is available now!