What are the responsibilities and job description for the Director of Clinical Operations, Phase I Enabling Studies position at LB Pharmaceuticals?
The Director will be responsible for oversight and conduct of LB’s Phase I Enabling Studies to lead completion aligned with project team goals and objectives. Post completion of the Phase I studies, the position will have the oversight to work on the LB-102 program where required. The Director will report to the leadership in Clinical Operations and 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 can either be a remote or hybrid position.
Responsibilities
The Director should have recent experience conducting Phase I Clinical Trials. Prior experience in schizophrenia, mood disorders, or related CNS indications is an advantage but not required.
- Accountability for the management of Phase I studies, including providing oversight to study the team to ensure on-time and within budget clinical trial execution and completion.
- Establish and manage the phase 1 clinical program in accordance with the Executive Management Team directives.
- Provide direction and execution of the phase I clinical programs in accordance with established timelines and budgets.
- Lead preparation of vendor requirements and project scope of the study vendors.
- Ability to work cross functionally and ensure alignment with other interdepartmental disciplines
- Ensure clear communication, accountability, and performance metrics are established and maintained.
- Ensure implementation of appropriate systems, standards, and processes in place to ensure quality at the level of investigative sites, vendors, and data.
- Review of Clinical Operations SOPs as needed
- Review and creation of document controls including the creation, approval, distribution, and retention of documents as well as the records produced by clinical operations.
- Oversight of clinical research organizations (CROs) and other key vendors to ensure timely and quality deliverables.
- Management of a Clinical Trial Manager as well as mentorship of other team members as applicable.
- Working with the Clinical Operations executive team to implement initiatives, process improvements, change management, and ad-hoc business projects.
- Develop working relationships with phase I organizations to ensure timely execution and completion of the phase I studies.
- Assist in the development of working relationships with potential Investigators, investigational sites, key opinion leaders in various neuropsychiatric areas, and vendors needed to support clinical trials, as needed.
- Oversight of relationships including. laboratories, third party vendors, etc.
- Ability to think strategically, identifying potential risks and implementation of solutions to mitigate risks
- Work with executive clinical operation team on risk management activities for clinical operations from program start through finish.
- Visit clinical sites to perform monitoring oversight visits and/or identify site challenges.
- Ensure clinical study sites are inspection ready.
- Contribution to the establishment of KPIs to measure vendor performance.
- Lead development and review of clinical study documents/plans and regulatory submission documents e.g. clinical study reports, etc.
- Assist with aspects of data review, data cleaning, data analysis and the availability of top line results.
- Ensuring the eTMF is inspection ready at all times.
- Prior work with Sponsor/FDA inspections nice to have.
- Ability to think creatively.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The list below is representative of the knowledge, skills and prior experience required.
- Bachelor’s degree required and Master's degree preferred.
- 12 years of clinical operations experience with at least 7 recent years' experience conducting phase I clinical trials.
- Demonstrated success in overseeing Phase I-IV clinical trials, either in biotech, pharmaceutical, or CRO environment.
- CNS experience is required, with neuropsych a plus.
- While not required, it is helpful if candidates have familiarity with DSM 5 and psychiatric scales utilized in clinical studies.
- Experience monitoring all types of data.
- Demonstrate understanding of the clinical program oversight, including monitoring of data, review of TLF, implementation and working of IRT, EDC development, vendor oversight.
- Some prior experience in a medical field, such as nursing or pharmacy a plus, but not a requisite based on previous experience.
- 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 30%.
- Ability to operate in alignment with LB’s values and culture.
- Other duties as assigned.
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
- 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.
Salary : $220,000 - $230,000