Director/Senior Director, Clinical Operations
Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit www.compasstherapeutics.com.
Our R&D team is seeking a onsite hands-on Director or Senior Director of Clinical Operations. This position will be report 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
At Compass Therapeutics, we provide employees with an inclusive offering of benefits and a competitive compensation package. We offer our employees competitive salaries, discretionary bonuses and meaningful equity participation. Our benefits support the health and wellness of our employees; from medical, dental and vision benefits to health reimbursement arrangement, flexible spending accounts, sponsored gym membership, and an employee assistance program. We 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.
We believe in growing and developing our team, and therefore, we invest in the development of strong values and culture. We are invested in employee success and provide tuition reimbursement, employee recognition programs and referral programs, training opportunities and maintain a comprehensive Performance Management cycle. While building a strong foundation, Compass culture can be seen every day in the form of curiosity, teamwork, passion, and cross functional collaboration.