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About the Role

The Director, Clinical Operations is responsible for the oversight and conduct of LB’s Major Depressive Disorder (MDD) clinical program, ensuring completion per established project team goals and objectives. This role reports to the Head of Clinical Operations and collaborates with cross-functional teams in a fast-paced, high-growth environment. The Director will ensure clinical trials are conducted on time and within budget, adhering to applicable GCP/ICH guidelines and regulatory requirements.

Responsibilities

Establish and manage clinical programs in accordance with Executive Management Team directives.
Draft and/or review Clinical Operations SOPs as needed.
Provide direction and execution of clinical programs according to established timelines and budgets.
Implement and monitor processes to identify and mitigate study risks.
Ensure clear communication, accountability, and performance metrics are established and maintained.
Oversee performance of laboratories and third-party vendors.
Maintain inspection-readiness across clinical programs.
Mentor junior team members.
Work with the executive clinical operations team on risk management activities from program start to finish.
Ensure clinical study sites are inspection-ready.
Visit clinical sites to perform monitoring oversight and identify site challenges.
Assist in the oversight of clinical research organizations (CROs) and other key vendors for timely and quality deliverables.
Lead preparation of vendor requirements, project scope, and selection of study vendors.
Contribute to the establishment of KPIs to measure vendor performance.
Implement appropriate systems, standards, and processes to ensure quality at the investigative site, vendor, and data levels.
Participate in the development and review of clinical study documents/plans and regulatory submission documents (e.g., DSUR, clinical study reports).
Assist with aspects of data review, data cleaning, data analysis, and the availability of top-line results.
Assist in the set-up and implementation of effective investigator and site monitor training, and facilitate operational and therapeutic area training for internal and external study team members.
Review/create document controls, including creation, approval, distribution, and retention of documents and records.
Work with the Clinical Operations executive team to implement initiatives, process improvements, change management, and ad-hoc business projects.
Demonstrate understanding of clinical program oversight, including data monitoring, TLF review, IRT implementation, EDC development, and vendor oversight.
Develop working relationships with potential investigators, investigational sites, key opinion leaders, and vendors needed to support clinical trials.
Perform other duties as assigned.

Requirements

Demonstrated success in overseeing Phase II-IV clinical trials, either in biotech, pharmaceutical, or CRO environment.
Familiarity with DSM 5 and psychiatric scales utilized in clinical studies.
Strategic thinker.
Bachelor’s degree required.
Some prior experience in a medical field, such as nursing or pharmacy, is a plus but not required based on previous experience.
12+ years of clinical operations experience.
Experience working with CROs to manage large global clinical trials.
CNS indication experience is required.
Experience monitoring all types of data.
Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices.
Excellent organizational skills and attention to detail.
Effective communication and interpersonal skills.
Able to set priorities, juggle multiple demands, and manage changing priorities.
Able to think critically and be a proactive problem-solver.
Able to work independently while exercising initiative, flexibility, and sound judgment.
Comfortable working with different levels of the company, including senior management.
Ability to travel approximately 25%.
Ability to operate in alignment with LB’s values and culture.

Skills

Clinical program oversight
Data monitoring
TLF review
IRT implementation
EDC development
Vendor oversight
DSM 5 familiarity
Psychiatric scales utilization

Location

Remote

Work Type

Remote
Full-time

Experience Level

12+ years of clinical operations experience
Director

Education Level

Bachelor's degree

Salary/Compensations

$220K – $230K

About the Company

Purpose Driven– We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments. We set competitive company goals to significantly and positively impact the lives of our patients, employees and shareholders. We have a sense of urgency to every action we make.
Transparent – We trust each other and expect honest and open communication to enable good decision making. We are humble, genuine and direct. Words match our behaviors. We hold each other accountable. We embrace the tough conversations to achieve success.
Bold – We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
Intelligent – We are curious, passionate and self-aware. We are agile, adaptable and seek diverse experience, knowledge, and skills to make informed, data driven decisions. We anticipate the needs of others, and we adapt quickly to challenges and find solutions. We rely on our collective experiences to diligently develop, strategically plan and efficiently execute our vision.
Unified – We collaborate as we strive for excellence. We rely on each other, and we have each other’s backs. We encourage constructive feedback to continually improve. We support each other; we laugh together. We celebrate each other’s successes and band together in times of hardship. We foster and appreciate genuine relationships.
Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.