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Biotech, R&D, & science

Vice President, Clinical Operations (San Diego) - Biotech, R&D, & science - San diego

Price: contact | USA, California, San diego,
Ad ID: 739286
Posted by: Unregistered user
Posted on Nov 13, 2017
Expire: Feb 11, 2018
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Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer from within.
Every member of our team plays a significant role in our success
Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal

The Vice President of Clinical Operations will provide strategic direction to the clinical operations group and is responsible for the overall management and performance of department functions including monitoring and data collection, outsourcing, vendor management, process development and improvement
The Vice President will actively participate in the organization and implementation of clinical operations activities; is accountable for providing clinical oversight and technical leadership for trial design and implementation activities.
Duties and Responsibilities Include But Are Not Limited To:
• Responsible and accountable for the execution of clinical studies.
• Develops and executes clinical trial operational strategies that are in compliance with applicable regulations and consistent with corporate standards

• Develops and maintains external network with CRO's to facilitate collaboration and successful clinical trial execution.
• Supervises the implementation, performance and monitoring of various clinical trials.
• Oversees the clinical study management and site management/support activities throughout the clinical study life cycle (strategy, design, planning, preparation, enrollment, reports)

• Leverages resources, expertise, and knowledge across projects to ensure deliverable attainment-develops staffing plans to appropriately align resources to workloads.
• Hires, trains, develop, mentors, and supervise senior clinical operations staff, study managers, and contractors

• Develops and implements clinical execution strategies working in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning.
• Oversees the preparation and management of budgets for studies and projects.
• Negotiates contracts and budgets with sites and vendors.
• Reviews and approves protocols for projects; reviews final study conduct documents such as study manuals, study tools, etc.
• Oversees site selection and qualification, reviewing and approving investigational sites
Participates in site selection committee and advises on final selection.
• Oversees investigator and coordinator meetings.
• Develops and utilizes appropriate metrics to assess performance, compliance, and cost effectiveness

• Establishes performance targets and monitors progress within the clinical organization.
• Reviews and approves corrective action plans at individual sites and across the study
Participates in internal/external study-related audits
Ensures that all Tocagen staff and vendors have adequate GCP training.
• Develops and maintains clinical research infrastructure such as the drafting and/or reviewing of SOPs and work instructions.
• Participates in or leads initiatives to improve overall organizational effectiveness, including working with quality and compliance reviews.
• Implements best practices and strict adherence to cGCP regulatory processes

• Able to interact with cooperative and other study groups.
• Able to interact with corporate partners.
• Ensure audit readiness at all times.
• Performs other duties as required.
Desired Knowledge and Abilities:
• Must have a demonstrated track record to independently manage and provide significant tactical, technical and leadership guidance to clinical operations team

• Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with all phases of the clinical research process and FDA regulatory requirements (i.e
GCPs, CFRs, etc.)
• Deep understanding of financial metrics with a proven ability to maintain operational control through the use of metrics and process ownership

• Capable of leading and inspiring others to accomplish specific tasks and achieve challenging business objectives through team development, coaching, and delegation

• Demonstrated ability to work with changes in business requirements, shifting priorities, and ambiguities.
• Experience in building the infrastructure that is required to effectively support the Clinical organization.
• Highly developed organizational abilities and project management skills.
• Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
• Computer skill should include proficiency with Microsoft Office software.
• High level of personal integrity, empathy excellent work ethics and respect for colleagues at all levels
Enthusiastic and deliverable-oriented.
Education and Experience:
• PharmD/MS/PhD degree preferred; or BS degree in science, nursing, health or related field with extensive operations experience.
• Minimum 10 years' relevant industry experience in clinical/medical research, PharmD, nursing or pharmaceuticals/devices

• Minimum 10 years' experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
• Minimum 8 years of prior clinical research experience and direct management experience

• Oncology experience preferred.
• Experience with regulatory submissions/filings preferred.
• Experience with corporate partnership experience preferred.
Reports To: Chief Medical Officer
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans
  • Principals only
    Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers

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Posted on Nov 13, 2017