Associate Director, Project Management

OncoBay Clinical is a full service CRO focusing on complex oncology indications including Immunotherapy and cellular therapies. We know that innovative research requires innovative operations and build that into our culture, systems and processes.  Our culture values and rewards critical thinking and open dialogue about quality — and that goes far beyond sole reliance on tools and checklists. We have an infrastructure to enhance access to patients, and integrated technology to provide higher quality and faster access to results. We remain vigilant and consistent with the advice in FDA Guidance on Monitoring, which encourages a quality risk management approach to clinical trial design and operation, and discourages a one size fits all mentality.

Are you ready to think outside the box and drive results? OncoBay Clinical might be the next right step to build your career and to make a difference.

BASIC FUNCTIONS:

Provides oversight and line management to Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects.  This includes managing the scope of work, objectives, quality deliverables, resources, risks, and other project management activities. Leads the operational contribution to proposal development and business development activities at a project level, providing input at a more strategic level by directly applying their therapeutic and/or operational expertise.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Acts as a primary senior-level contact for customers; represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
  • Ensure all studies assigned are conducted to reflect the therapeutic or client specific requirements.
  • Ensures each study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations.
  • Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
  • Apply study specific learning across assigned portfolio of studies/clients.
  • Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
  • Leads operational input to proposal development, pricing, and bid defenses, including proposed operations strategy; participates in Request for Information (RFIs).
  • Drives performance improvement, operational efficiencies, and innovative strategies.
  • Directs others to resolve highly complex or unusual business problems that affect major functions or disciplines.
  • May plan, coordinate and present at internal and external meetings, including Steering Committees.
  • Participates in the development of Standard Operating Procedures (SOPs), tools, training, staffing requirements, etc.
  • Interacts with Executive management and contributes scientific/medical input to other departments, as appropriate.
  • Ensures quality standards are set and maintained over all areas of responsibility.
  • Provides line management oversight and contributes to leadership of Project Management as an operational and therapeutic area expert.
  • Other tasks and duties as determined appropriate by Executive Management.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology
  • Demonstrated knowledge of oncology therapeutic area and early phase research design.
  • Demonstrated ability to lead multidisciplinary teams of professionals, including vendor management.
  • Demonstrated experience in client service in the clinical research
  • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Strong ability to manage time and work independently
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
  • Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
  • Ability to travel domestically and internationally and to meet with clients in their offices.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA

  • Ability to travel domestically and
  • Very limited physical effort required to perform normal job
  • Ability to successfully present and win business from clients
  • Ability to write effectively and present in all forums

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. Advanced degree preferred.
  • Minimum of 7 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses; at least 5 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies, or equivalent experience. At least 3 of the 5 years of CRO experience must be in a substantial management position(s) with responsibilities including both project management and clinical management.
  • 5 years of oncology clinical or research experience, including Immuno-oncology. Cell therapy preferred.
  • High level of competency in English language
  • Proficiency with MS Office Applications, including MS Project.
  • Ability to travel as necessary (up to 50%)

Location: Remote - U.S.

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