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Senior Director, Clinical Operations

Compass Therapeutics is a biopharmaceutical company focused on drugging the immune system to treat human diseases.  Using its proprietary antibody discovery and screening platforms, Compass has generated a portfolio of next generation immunomodulatory biologic drug candidates, drug combinations, and multispecifics addressing unmet medical needs in oncology, autoimmunity and other diseases.

Our Medical Department is seeking a hands-on Senior Director, Clinical Operations at our Cambridge, MA site. This position will report to the CMO.

Principal responsibilities:

  • Ensure that clinical-stage programs achieve on all related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
  • Develop, maintain, and report on program budgets, including long-range forecasting and monthly accruals, in support of Compass financial goals
  • Establish and lead 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 selection and oversight of CROs and other vendors/ external partners
  • Lead activities related to the planning and implementation of all clinical development programs globally, including study start-up, operations/ execution, risk identification and remediation, completion and reporting in accordance with the Development Plan.
  • Build and maintain effective relationships with Investigators, KOLs, patient advocacy groups, regulatory agencies in implementation of study protocols, collaboration on feedback, etc.
  • Build process for- and oversee medical writing, including contributing to-/ 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
  • Drive an innovative, collaborative, and motivational culture
  • Cure Cancer

Preferred Qualifications:

  • 10+ years of experience with pharmaceutical or biotech company, with at least 5 years’ domestic and international study leadership experience across all phases of clinical development
  • 2-5 years in a supervisory role managing clinical operations staff
  • Advanced degree in science or business
  • 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
  • Extensive 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 communication skills
  • Strong interpersonal, analytical and organizational skills, and demonstrated success in project and portfolio prioritization and management
  • Ability to work in and drive a team-oriented environment, motivate and influence others, lead strategic discussions, and interact with critical internal and external stakeholders, including the Clinical Development Core 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
  • Willingness to travel domestically and internationally (up to 30% of time)
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