Director/Senior Director, Clinical Operations
450 Kendall Street Boston, MA 02135 US
This position reports onsite to our open CMO position, and in the meantime to our Co-founder & CEO.
- Ensure that our 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
- Establish and drive a team of internal and external multi-functional stakeholders focused on program management and study execution; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including oversight of CROs and other vendors/external partners
- 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
- Build and maintain effective relationships with Investigators, KOLs, patient advocacy groups, regulatory agencies in implementation of study protocols, collaboration on feedback, etc.
- 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
- Continue to build on our innovative, collaborative, and motivational culture
- May require domestic and international travel
- 10+ years of industry experience, with at least 5 years’ domestic and international study leadership experience across all phases of clinical development; 2-5 years 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
- Thorough understanding of cross-functional processes involved in study design and execution, including protocol development, data management, safety/ pharmacovigilance, biostatistics, medical writing, quality assurance, regulatory- and medical- affairs
- Excellent oral and written business communication skills
- Strong interpersonal, analytical and organizational skills, and demonstrated success in project and portfolio prioritization and management
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
- Including but not limited to the leadership team, Principal Investigators, KOLs, CRO partners, patient advocacy groups, and regulatory agencies
- Proficiency in implementing and utilizing clinical database software/TMS, and other relevant programs such as Microsoft Office Suite
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.