CK Group are seeking a two hands-on Directors or Senior Directors of Clinical Operations to join a clinical-stage, oncology-focused biopharmaceutical company who develop antibody-based therapeutics to treat human diseases. These positions will initially report onsite to the Co-founder & CEO and then the CMO later on.
These Directors or Senior Directors of Clinical Operations will be on a full time, permanent basis located in Cambridge, MA.
• Ensure that the clinical-stage antibody programs are on track to reach related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
• Lead strategic planning and activities related to the implementation of all clinical development programs globally, including study start-up, operations, execution, risk identification and remediation, completion, and reporting
• Develop, maintain, and report on program budgets, including long-range forecasting and monthly accruals, in support of Compass financial goals
• Build process for and oversee medical writing, including contributing to and authoring documents such as study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and sections of regulatory submission documents; create and maintain appropriate standard operating procedures (SOPs) and compliant management of clinical records
• Partner effectively with essential subject matter experts in data management, safety/ pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs
• Significant industry experience, including domestic and international study leadership experience across all phases of clinical development; experience in a supervisory role
• Advanced degree in science or business required
• Thorough knowledge of drug discovery and development program management, from IND- through BLA; as well as experience in preparation of clinical sections of INDs, BLAs/ MAAs
• Proven experience in CRO/vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation
• Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA, as well as those defined by international regulatory bodies in specific locations
Competitive salaries, discretionary bonuses and meaningful equity participation. Health and wellness support; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, and an employee assistance program. They also provide company matched 401(k) and Roth 401(k) programs and other tools for financial wellness. Additional benefits include commuter reimbursement, subsidized parking, and substantial paid time off including a winter shut-down week.
Entitlement to work in the USA is essential. For more information or to apply for these Directors or Senior Directors of Clinical Operations positions, please contact Hannah Oakley or Alex Tosney on +1 617 692 2948 or email USA@ckscience.com. Please quote 52637 in all communications.
Full Job Description will be available upon request.