drjobs Sr Director Clinical Operations Supira Medical

Sr Director Clinical Operations Supira Medical

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1 Vacancy
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Job Location drjobs

Los Gatos, CA - USA

Monthly Salary drjobs

$ 200000 - 240000

Vacancy

1 Vacancy

Job Description

Supira Medical a clinicalstage Shifamed Portfolio Company is developing a lowprofile high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical please visit www.supiramedical.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description
The Sr. Director Clinical Operations will have extensive experience with managing large diverse multicountry project operations and experience building motivating and developing teams. They will have the ability to work in a fastpaced environment and have broad functional experience in areas of strategic planning clinical and project operations client delivery. With the ability to work across functions and within an executive team to drive change in a positive collaborative and transparent way. They will also have a positive energetic and flexible attitude with a reputation for being a results and deliveryoriented selfstarter. This is a full time onsite position and will require reporting to our offices located in Los Gatos CA.
Responsibilities Skills & HandsOn Experience
  • Oversees large diverse multicountry project operations with primary focus on clinical sites management and sites monitoring to ensure clinical trials are performed on schedule within budget and meet all quality and regulatory requirements.
  • Oversees the project initiation and planning processes by reviewing and approving project plans work breakdown structure project schedule and overall budget.
  • Participates in project review meetings and analyzes project performance reports; reviews and approves changes to the plan and project and/or change orders if necessary.
  • Manages and optimizes interdependencies between projects and coordinating communications across projects.
  • Provides daytoday leadership guidance and supervision to managers who are responsible for ensuring the highquality of projects and Sponsor relationships.
  • Responsible for training mentoring managers and team members in project team.
  • Participates in strategic planning direction and of business development initiatives.
Education & Work Experience
  • Bachelors Degree or University equivalent in a scientific discipline is required; Masters Degree is preferred
  • 15 years of successful experience in a scientific discipline including 10 years in the area of clinical operations is required
  • Strong knowledge and understanding of clinical operations device development process including direct project and clinical trials oversight.
  • Excellent skills in designing and managing global clinical trials and the ability to contribute strategically of clinical development programs from firstinman through lifecycle management. Must be able to form and articulate a clear vision to successfully guide all clinical team members (e.g. internal staff and external investigators/consultants).
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word Excel PowerPoint and Outlook). Ability to implemented and transition to electronic tools and systems
  • Good verbal and written communication skills
  • Previous supervisory experience with excellent leadership skills with the Lead by Example approach
  • Working knowledge of electronic data collection systems and experience managing contract research organizations.
  • Have knowledge of ISO 13485; 2003 FDAs Code of Federal Regulations (clinical related regulations) and GCP regulations.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your jobrelated knowledge skills experience relevant education and training/certifications. In addition to those factors we also examine internal equity as well as consider current market rate and title may be assessed one level lower or higher accordingly. After you join the company your performance contributions and results along with business and organizational needs will affect your base salary. The base salary range for this fulltime position is between $200000 to $240000 equity benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to


Required Experience:

Director

Employment Type

Full Time

Company Industry

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