Senior Director Clinical Operations

Company: The American College of Radiation Oncology
Location: Sunnyvale
Posted on: February 18, 2021

Job Description:

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert-- System, we've taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews). Are you a leader in the field of medical device (IVD preferred), biotech, or pharmaceutical with extensive experience in Clinical Operations? Cepheid is looking for a Sr Director of Clinical Operations for our site in Sunnyvale, CA or Chicago, IL to Plan, implement and lead clinical trials and influences study design as well as interpret results. You will have the opportunity to define clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations! The successful candidate will coordinate and supervise the Clinical Operations department and external clinical review organization to oversee clinical studies on going in the field. The objective is to improve the acceptance and accurate utilization of products by healthcare professionals and is accomplished by generating, collecting, interpreting and presenting medically significant, clinically useful, accurate information. Essential job responsibilities: Develops and implements strategies for clinical trials. Directs the design, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Monitors adherence to protocols, standard operating procedures and resolves study completion. Develops and maintains good collaborations with premier scientists in the field, in order to monitor priorities in the field, identify outstanding questions, and to review the literature to identify policy questions, or to predict market developments. Reviews pertinent literature, prepares white papers, and provides education to Cepheid staff as needed. Monitors developments in the field of interest in order to be able to assess competitive activity, market development, and to find opportunities to broaden service utilization. Lead the budgeting and planning necessary to support this department. Review both clinical and analytical sections for regulatory submissions. Collaborate with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO) authorities regarding clinical research in support of product registration. Provides leadership and mentorship to others especially those in the Clinical Affairs group. Play a role in the support of, and access to, Cepheid's products in a diverse group of Private, Public, Federal and State payers regionally (Managed Care encompasses HMOs, third party payers, GPOs and IHNs), to ensure end-user access and secure rapid introduction and uptake of new products. Interacts internally and externally with executive-level management requiring negotiation of very difficult matters to influence policymaking bodies both internally and externally. Serve as principal medical monitor responsible for the implementation of clinical trials and for the interpretation of the results of phase 1-4 investigations, as well as working with a team to author scientific publications. TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time
• For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time. Education and Experience (in years):
  • Bachelor's degree in a scientific discipline with 14+ years experience OR
  • MS/PhD with 12+ years of relevant experience within medical device (IVD preferred), biotech, or pharmaceutical
  • 4+ years of people management experience Knowledge and skills:
    • Have a proven track record in acquiring FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, either in cancer or infectious disease diagnostics.
    • Must have demonstrated accomplishment in obtaining diagnostic product clearances/approvals through U.S. FDA, and successful audits/inspections of clinical evaluation sites.
    • Ensures budgets, schedules, and performance requirements are met.
    • Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
    • Previous management or project experience.
    • Travel requirements up to 20% in non-pandemic times Preferred requirements:
      • A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here . Job Information
        • Job ID: 55652904
        • Location:
          Sunnyvale, California, United States
        • Position Title: Senior Director Clinical Operations
        • Company Name: Cepheid
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Keywords: The American College of Radiation Oncology, Sunnyvale , Senior Director Clinical Operations, Executive , Sunnyvale, California