Senior Director Clinical Operations
Company: The American College of Radiation Oncology
Location: Sunnyvale
Posted on: February 18, 2021
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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)
Sunnyvale, California, United States
Keywords: The American College of Radiation Oncology, Sunnyvale , Senior Director Clinical Operations, Executive , Sunnyvale, California
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