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Vice President, Clinical Operations

Position Summary:
Achaogen is a fully integrated research, development and pre-commercial stage biotechnology company that is preparing to launch its first product and has built a strong pipeline that is committed to addressing major public health needs. This is an exciting opportunity to provide leadership to a function that is pivotal to the success of our business.

The VP of Clinical Operations will be responsible for the strategic execution, and management of clinical operations supporting the Company’s development and medical affairs activities, in compliance with GCP, industry standards, and global regulations. S/he will lead and provide oversight for the clinical operations function including CRO management for investigational and marketed products. She/he will identify and drive strategic initiatives for clinical trial process improvements. This position will also be a member of the Development Leadership Team.
 

Essential Job Functions:

  • Primary leadership role for overall clinical operations strategy across multiple clinical research trials Phase I-IV
  • Accountable for the planning, oversight, management and delivery of clinical trials, including the clinical outsourcing management and financial oversight of clinical programs.
  • Planning and conducting multiple Phase I–IV and post launch Achaogen clinical trials, providing strategic and tactical input into clinical development timelines; develop study specific goals, and track metrics
  • Leadership and management of a diverse group of people, ensuring professional development and leadership capabilities at each level
  • Responsible for driving innovation and efficiencies in the design and execution of all clinical trials and adapting the right clinical operating model, including technology platforms (i.e. CTMS, Risk Based Monitoring technology)
  • Accountable for ensuring that trials are designed to meet the evolving needs of patients, investigators, payer and regulatory authorities
  • Responsible to deliver trials that not only support approval of Achaogen products but differentiates our compounds in the market and enables the commercial/financial value of our compounds post approval
  • Accountable for strategy around insourcing, outsourcing and management of strategic alliances with CROs and external partners
  • Participates in Company leadership and executive team meetings representing Clinical Operations
  • Supports clinical operations aspects of submissions to FDA and other regulatory authorities
  • Supports the preparation and planning of study protocols, statistical analysis plans and clinical study reports
  • Leads the efforts to develop and refine processes to govern all Clinical Operations and CRO activities within the purview of Clinical Operations including vendor selection, operational systems and related SOPs, such as study planning, selection of study sites and investigators, and the conduct of clinical trials
  • Demonstrated ability to develop and revise service agreements, budgets, plans and timelines to ensure that CRO performance expectations are clearly spelled out in contracts and that CRO commitments are met
  • Accountable for ensuring that clinical monitoring activities for sponsor studies are conducted in compliance with ICH/GCP guidelines and applicable regulations, policies and ethical standards
  • Accountable for ensuring that site study materials, investigator contracts, and site payments are managed and documented appropriately and are kept within the scope of the contracts / budget and in compliance with regulatory requirements
  • Develops and implements a risk evaluation and mitigation processes as it pertains to the conduct of clinical trials
  • Accountable for ensuring that trial master files and other clinical trial documentation is maintained in real time and in compliance with applicable guidelines and regulations
  • Monitors effectiveness of departmental SOPs and processes and performance against key GCP Quality metrics
  • Establishes, communicates and ensures key study performance indicators are met
  • Proactively anticipates and plans for potential study issues/risks and implements timely solutions
  • Collaborates with functional managers to assure integration of project, company, and functional goals towards achieving clinical project milestones
  • Works effectively with Technical Development and Quality group to oversee the packaging, labeling and distribution of study drug supply from manufacturer to study sites
  • Provides mentorship to direct reports and maintains clear communication on performance to direct reports
  • May serve as a member of the due diligence team to assess potential licensing and acquisition opportunities in terms of risks, activities and costs associated with Clinical Ops Requirements

Experience, Abilities and additional Job Requirements:

  • Demonstrated ability to build, lead and run a best-in-class clinical operations team
  • Demonstrated ability to collaborate effectively within a matrixed organization
  • Expert knowledge of clinical study conduct and data management
  • Minimum of 10 years of clinical operations experience
  • Minimum of 3 years leading a clinical operations group
  • Experience managing all phases of clinical trials from IND through to post-marketing
  • Demonstrated ability to lead the selection of the CROs and vendors that best address and support our overall business success
  • Has established master service agreements that that include clear expectations around CRO performance and establish plans that hold CROs accountable and on budget throughout the period of contract performance
  • Expert knowledge of relevant FDA and EMA regulations, ICH Guidelines, and other applicable regulations and a demonstrated ability to reduce these to good operating principles and practices.
  • Runs Clinical Operations in compliance with global regulatory requirements
  • Expert knowledge of TMF standards and ability to conduct a risk based assessment of CRO TMF capabilities
  • Ensures there are clear TMF operational agreements and expectations established between study leads and CRO project managers
  • Experienced in planning for and participating in audits and inspections with a commitment to ensuring a successful outcome
  • Strong analytical and management skills
  • Excellent teamwork and collaboration skills
  • Ability to direct the day-to-day work of others and the ability to recruit, develop and retain high performing employees.
  • Ability to organize and prioritize work schedules based on business priorities of your team on forward-looking planning basis
  • Current US work authorization required
  • Ability to travel domestically and internationally

Preferred Education:

  • BA/BS degree, advanced training in a scientific or a health care field preferred

Achaogen Vice President Level Competencies and Requirements:

  • Enterprise level thinking that puts the business first
  • Inspires others to excel
  • Attract, develop and retain top talent
  • Creates a high-performance culture that executes
  • Has exceptional self-awareness
  • Optimizes self-development
  • Shapes innovation
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive
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