Job Description
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health.
Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
Definium Therapeutics is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals with the desired experience and skillsets to strengthen our team of patient-centric, intelligent individuals.
Overview As a Senior Director, Clinical Data Management (DM), this role will be responsible for the clinical data strategy and data quality across all clinical programs (early or late phase). This role will ensure that clinical trial data collection is aligned with design objectives and supporting data analysis, while providing input to regulatory filing and drug product commercialization from a clinical trial data point of view. Reporting to the VP, Head of Biometrics and Data Science, this role will provide centralized leadership for DM activities, oversight of DM deliverables to ensure high quality, and drive operational efficiencies to meet timelines. This role will strengthen cross functional partnerships with Clinical Operations, Clinical Development and Medical, and will lead DM technology roadmap to support scale. Working closely with other functions, DM group, Biostatisticians and Statistical Programming team, this role will oversee external vendors deliverables to ensure that clinical trial data quality and integrity meet high standards and the traceability between raw trial data and analysis datasets. This role will also be responsible for developing and maintaining DM SOPs and processes and ensuring compliance with the trial master file requirements.
Responsibilities: - Provide managerial and technical leadership for the Data Management group within the Dept of Biometrics and Data Science; coach and grow direct reports and build a team of high collaboration and productivity
- Ensure all data management activities supporting clinical trials, from building study databases, collecting and cleaning data as the trials are ongoing, to achieving study database locks, are delivered of high quality and meeting timeline
- Oversee DM vendors and/or data collection vendors' deliverables from quality to timeline while maintaining mutual respect and strong collaboration
- Examine and ensure an effective and efficient data review/cleaning process to prepare for clinical trial database lock by leading multi-functional effort, including Clinical Operations, Clinical Development and Medical, to participate in thorough data review
- Serve as a lead Clinical Data Management for one or two clinical programs as needed
- Provide input to protocol development and provide input to other clinical study documents and/or regulatory filing dossier as needed
- Responsible for data management budget creation, management, and invoice review
- Create procedures and processes that delineate accountability and responsibilities of different functions who are involved in clinical trial data collection, review and cleaning
- Create necessary SOPs and guidance to ensure data management activities are compliant from quality standpoint and DM related documents are compliant with the trial master file (TMF)
- Partner with Biostatistics, Statistical Programming and Data Science colleagues to build an organization of mutual trust and strong collaboration to achieve common goals
Requirements: - Master's degree with 18+ years of experience in clinical data management within the biotech or pharmaceutical industry
- 13 + years of experience in managing Data Management group
- Strong track record in building the team, growing direct reports, and taking team's performance to the next level
- Extensive hands-on experience in performing DM activities from database design, data review/cleaning to database lock
- Solid knowledge in clinical trial data management processes, tasks, and tools; familiarity with CDSIC standards
- Strong track record in managing DM vendors to resolve data issues and achieve quality study database lock
- CNS trial data management experience or solid experience in ePRO/eCOA data collection with good understanding about statistical analysis approaches for CNS clinical trials
- Deep understanding of regulatory guidance, quality compliance, and data privacy pertinent to clinical trial participants
- Demonstrated capacity of collaboration with Clinical Operations, Clinical Development, Medical, Biostatistics and Statistical Programming, and relevant functions to achieve common goals
- Strong organizational and project management skills; demonstrated interest in continued learning and growing
- Detail-oriented and hold high standards of excellence for own work products
- Deliver and communicate effectively in the work-from-home environment
- Excellent interpersonal skills and is a good team player
Preferred Experience: - Experience with data visualization tools (e.g., Elluminate)
- Programming skills to generate data listings that can assist in revealing data issues (e.g., experience of using Python
The starting base pay range for this position is $233,407.00 - $276,236.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
Job Tags
Work from home, Flexible hours,