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Director Clinical Operations

Conditions of Employment:

Salubris Biotherapeutics, Inc. (or SalubrisBio) is a science-driven biotechnology company dedicated to the discovery and global development of novel complex biologics for the treatment of cancer, cardiovascular and neurodegenerative diseases. We strive to develop novel therapeutic molecules which provide clinically meaningful improvements in disease burden and quality of life to patients with significant medical needs.

Primary Responsibilities:

SalubrisBio is seeking a highly motivated full-time Senior Director / Director of Clinical Operations who will provide leadership, project management, and program oversight to plan and conduct multiple high quality clinical trials concurrently. Candidates should have strong ability in multi-tasking and are expected to work in a fast paced, innovative, and dynamic environment.

Responsibilities

  • In close collaboration with the Chief Medical Officer, the Director of Clinical Operations will be leading all operational aspects of clinical development activities
  • Provide strategic direction for clinical operations activities to address key challenges of execution of the Clinical Ops program with innovative and lean solutions
  • Provide direct oversight and management of clinical operation activities in-house and outsourced to clinical research organizations (CROs)
  • Build the clinical operations team in a growing organization
  • Assist the CMO in the development of clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
  • Ensure that clinical trials are properly resourced, managed, and executed in accordance with timelines and industry standards (e.g., GCP, GLP, ICH guidance)
  • Review/develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required
  • Function as the primary contact for trial(s) between other departments
  • Draft clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, and other FDA submissions
  • Monitor, review and summarize safety and efficacy data in ongoing studies
  • Develop relationships with appropriate consultants
  • Write/edit abstracts and present data at scientific meetings, both internally and externally
  • Manage third party vendors and resources
  • Provide general operational support, including business analysis
  • Identify any gaps in company/CRO SOPs and develop internal SOPs as needed

Job Requirements:

Required education and experience

  • BS Degree in nursing or scientific/life-sciences field required. MS or Pharm.D. or Ph.D. preferred
  • At least 10 years’ experience in managing clinical trials with at least 5 years of experience in clinical operations/project management within the biopharmaceutical industry
  • CRO management experience required
  • Prior Oncology/ CNS/ Cardiovascular Drug Development experience preferred
  • Regulatory and/or non-clinical research or CRO experience highly desirable

Qualifications

  • Working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
  • Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
  • Ability to work well with diverse functional teams to coordinate activities and achieve project goals
  • Strong analytical, problem solving, critical thinking, organizational and planning skills
  • Demonstrated leadership capability
  • Excellent communication, negotiation, and interpersonal skills
  • Organized, results-oriented, proactive strategic thinker
  • Possesses excellent team building, training, and facilitation skills
  • Seeing the big picture and acting in anticipation of future needs or necessary adjustments for achieving desired objectives
  • Outstanding project management and ability to multitask and perform in a fast-paced entrepreneurial and growing environment
  • Demonstrated understanding of the biotech/pharma industry and therapeutic product development
  • Passionate about scientific innovation, self-starter, goal-driven, and strive to continuously build knowledge and skills for personal, professional, and organizational growth

Benefits:

SalubrisBio is an Equal Employment Opportunity employer. Benefits include:

  • Hybrid work opportunities ( 2 -3 days in office at the discretion of the manager)
  • Competitive pay
  • 401(k) with company matching
  • Free medical insurance
  • Flexible Spending Accounts (FSA) and Health saving Account (HSA)
  • Free life insurance
  • Paid time off
  • Tuition reimbursement
  • Cell phone stipend
  • Free snacks, and drinks

Qualified candidates should email their resume to alida.simon@salubrisbio.com. Position is based in Boston, MA