Director/ Sr. Director Clinical Operations

POSITION SUMMARY:

Reporting to the Senior Vice President, Clinical Operations, the Director/Sr. Director, Clinical Operations is responsible for providing leadership to assigned clinical studies and for ensuring studies within a program are being managed in accordance with the BlueJay’s overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a clinical program comply with the company’s procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Director, Clinical Operations is also responsible for the development and implementation of clinical best practices for effective clinical study execution in accordance with regulations and from time to time may lead strategic and continuous improvement initiatives in clinical project execution and project management. Onsite attendance is required 3 days a week.

PRIMARY RESPONSIBILITIES AND DUTIES:

• Provides leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Lead.
• Collaborates with the SVP, Clinical Operations, to ensure alignment of resources and budgets across clinical studies by evaluating timelines and prioritizing tasks.
• Provides leadership to ensure trial/study teams, are managed in alignment with clinical program and company goals.
• Provides Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to SVP, Clinical Operations, and other relevant stakeholders.
• Responsible for the strategic and operational oversight, management, execution and delivery of the clinical studies for one or more studies.
• Represents the Clinical Operations at the Project Team (PT), to discuss urgent operational questions and to provide strategic operational input to the PT.
• Resolves and/or escalates issues raised by the clinical operations team or the SMT.
• Takes a lead role in vendor selection, including critical review of contracts and negotiation of work orders.
• Oversees CROs and other selected vendors including setting and monitoring key performance indicators and ensuring successful execution of program/studies.
• Acts as the main escalation point of contact for strategic CRO partner(s) for the assigned program and for the key stakeholders in clinical operations.
• Ensures consistency between studies.
• Provides input and clinical operations perspective on clinical trial design.
• Oversees financial aspects of assigned clinical study(ies) and ensuring adherence to planned study budgets.
• Provides direction for strategic initiatives/oversees implementation of those initiatives for process and operational improvements.
• Oversees/co-leads inspection readiness activities and acts as subject matter expert during regulatory inspections.
• Works closely with Quality Assurance on SOP development.

QUALIFICATIONS AND SKILLS:

• Bachelor of Science degree with ten plus (15 ) years’ experience; MS/RN with eight plus (12 ) 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.
• Hybrid work model ( 3 Days a week in office). 

PHYSICAL DEMANDS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.

• 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 25% 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 competitive benefits, and an environment where you will have the opportunity for personal and professional growth. The salary range for this position is $240,000 to $260,000 USD.

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.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

ABOUT BlueJay Therapeutics Inc.

Bluejay is on a mission to illuminate a path toward curative treatments for serious viral and liver diseases.

At Bluejay, we are discovering life-changing medicines and cures for people with viral and liver diseases, starting with chronic hepatitis B (CHB) and chronic hepatitis D (CHD).

We each embody a passion and connection to our purpose, and we are unified in envisioning a world where a functional cure is possible for everyone with CHB/CHD. We believe it’s a question of when, not if.

For more information about us, please visit https://bluejaytx.com/.