Sr Director Clinical Operations (M/W)

JOB SOURCE: HEADHUNTER
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  • Fast growing biotech company
  • Oncology

Company

Our client is a promising start-up organization specialised in Oncology.

Role

  • Responsible for strategically planning clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
  • Implement processes and help to build a Clinical Operations organization to successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives.
  • Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials.
  • Recruit, train, mentor and retain top-tier clinical operations personnel to achieve program objectives.
  • Effectively communicate a vision for the success of the program, foster team work to ensure timely and high-quality deliverables, demonstrate efficient and clear decision making, and foster principles and values that place patients and quality first.
  • Effectively identify and manage external vendors to provide high-quality deliverables within established timelines and budgets.
  • Work collaboratively and communicate effectively with all functional area representatives within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals.
  • Ensure Clinical Operations is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law.

Candidate

  • BA/BS required, advanced degree with scientific or health-care training preferred and minimum of 10 years professional pharmaceutical development experience, with a minimum of 6 years leadership experience.
  • Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced with early to late stage clinical trials, and with the IND to BLA process.
  • Able to manage clinical operations for a product from pre-clinical through all clinical phases and product launch.
  • Demonstrated leadership in a clinical operations role, effective organizational skills, and excellent verbal and written communication.
  • Willingness and ability to travel domestically and international as required.
  • Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S., building clinical operations infrastructure, including SOPs, and managing vendors.
  • Experience with Clinical Operations line management, and mentoring and developing personnel.
  • Extensive experience managing contracts (vendor and site) and clinical finance activities.
  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
  • Independently motivated, detail oriented and good problem-solving ability.

Deal

Great opportunity to join a dynamic, innovative and fast-growing company.

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