Director of Clinical Operations-CNS Experience Required

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

The Director will:

• Establish and manage clinical programs in accordance with the Executive Management Team directives
• Draft and/or review of Clinical Operations SOPs as needed for the company
• Provide direction and execution of clinical programs in accordance with established timelines and budgets.
• Implement and monitor processes to identify and mitigate study risks.
• Demonstrated success in overseeing Phase II-IV clinical trials, either in biotech, pharmaceutical, or CRO environment.
• Ensure clear communication, accountability and performance metrics are established and maintained.
• Performance oversight (e.g. laboratories, third party vendors, etc.)
• Have familiarity with DSM 5 and psychiatric scales utilized in clinical studies.
• Strategic thinker

Responsibilities

• Accountability for the overall management of assigned clinical studies), including providing strategic direction to study teams to ensure timely clinical trial execution and completion.
• Maintain inspection-readiness across clinical programs.
• Possible mentorship of junior team members.
• Work with executive clinical operation team on risk management activities for clinical operations from program start through finish.
• Ensure clinical study sites are inspection-ready.
• Visit clinical sites to perform monitoring oversight visits and/or identify site challenges.
• Assist in the oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
• Lead preparation of vendor requirements and project scope and selection of study vendors.
• Contribution to the establishment of KPIs to measure dvendor performance.
• Implementation of appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data.
• Participate in
  development and review of clinical study documents/plans and regulatory submission documents e.g. DSUR, clinical study reports, etc.
• 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; facilitation of operational and therapeutic area training for internal and external study team members.
• Review/creation of document controls including the creation, approval, distribution, and retention of documents as well as the records that are produced by clinical operations.
• Working with the Clinical Operations executive team to implement initiatives, process improvements, change management, and ad-hoc business projects.
• Demonstrate understanding of the clinical program oversight, including monitoring of data, review of TLF, implementation and working of IRT, EDC development, vendor oversight.
• Develop working relationships with potential Investigators, investigational sites, key opinion leaders in various therapeutic areas, and vendors needed to support clinical trials, as needed.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree required 
• Some prior experience in a medical field, such as nursing or pharmacy a plus, but not a requisite based on previous experience.
• 12+ years of clinical operations experience, as well as 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 level management.
• Ability to travel approximately 25%.
• Ability to operate in alignment with LB’s values and culture.

The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $220K – $230K

The Values We Hope You Share  

1. 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.  

1. 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.
   

1. Bold – We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
   

1. 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. 
   

1. 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.