Senior Director Clinical Affairs
Company: Dexcom Inc.
Location: San Diego
Posted on: February 22, 2021
Job Description:
Dexcom, Inc. empowers people to take control of diabetes through
innovative-- continuous glucose monitoring (CGM) -- systems.
Headquartered in San Diego, California, Dexcom has emerged as a
leader of diabetes care technology. By listening to the needs of
users, caregivers, and providers, Dexcom simplifies and improves
diabetes management around the world. Summary:
The Senior Director, Clinical Affairs will lead our clinical
research activities in the design and execution of clinical trials
to support approval and commercialization of Dexcom's medical
devices. Reporting directly to the Vice President, Clinical
Affairs, the role will be responsible for overseeing the Clinical
Team in the develop of clinical strategies and the planning,
conducting, and monitoring of multiple clinical trials within the
US and globally of varying size and complexity. Clinical trials and
analysis will include those designed to support regulatory
submissions, reimbursement, CGM category and Dexcom share of
category growth. The role will work in close collaboration with
R&D, Regulatory, Marketing, Quality, Data Management and
Biostatistics.
-- Essential Duties and Responsibilities:
- Leads the Clinical Team of in-house and field-based Clinical
Research Associates in the execution of clinical studies
- Ensures the logistical details, study protocols, enrollment,
training needs, milestones, clinical study reports, budgets and
timelines are met for all studies
- Develops and execute clinical strategies, as well as identifies
and implements best practices to increase effectiveness and
efficiency of the organization and execution of clinical
studies
- Ensures that Dexcom sponsored clinical trials and studies are
executed in accordance with Food and Drug Administration (FDA)
regulations, Institutional Review Board (IRB) approval, and Good
Clinical Practices (GCPs)--
- Builds strong relationships with clinical site staff
(PI's-MD's), investigators, other medical professionals, and
Contract Research Organizations (CROs) to ensure proper
prioritization and execution of our clinical trials and
studies
- Builds relationships and collaborates with key opinion leaders
to help develop strategies and priorities for the clinical
organization
- Designs and directs clinical studies to include building
patient and physician education and product materials
- Collaborates and influences R&D, Quality, Regulatory and
other leaders around product improvements, technologies,
intellectual properties and other clinical issues
- Collaborates with Marketing and New Markets to develop and
identify studies to support commercial operations
- Partners with Data Management and Biostatistics leadership to
ensure that clinical studies are properly planned, performed and
analyzed
- Develops resource management strategies to support clinical
studies to include ensuring the right number of resources and
budget allocation
- Ensures that budgets, on-time completion of clinical
milestones, and performance requirements are met
- Plans and assists with the preparation of regulatory
submissions (e.g., IDEs, PMAs, and PMA supplements).
- Organizes project and departmental objectives and delegate
tasks effectively--
- Implements legal requirements of contracts, non-disclosure
agreements, and financial agreements in clinical programs--
- Ensure forms and other site regulatory documents are complete
and accuracy, while ensuring compliance with FDA, Health Canada,
EU, other International requirements and Good Clinical Practices
guidelines.
- Create study-specific manuals, guidelines, and forms to
effectively implement protocols and provide input for the
development of protocols.
- This position assumes and performs other duties as assigned.
Required Qualifications:
- Results-oriented, self-disciplined, fast-paced, motivated
individual that requires minimal supervision and able to multitask
several projects at one time.
- Proven track record of successfully designing, planning and
executing medium to large scale clinical studies, to include
creative study design, resource planning and budgeting, contingency
planning and timely execution--
- Ability to deal with ambiguity - ready and able to effectively
and efficiently change plans quickly to meet the changing needs of
the business and projects--
- Highly collaborative and desire to reach across the
organization to understand needs and how to meet those needs.
- Proven ability solving complex problems, with the ability to
get to true problem that needs to be solved and foresee problems
and proactively mitigate before they happen
- Ability to ruthlessly priorities own active and teams to ensure
spending time on the critical few priorities that are most
important to the organization
- Proven ability to effectively influence both internal and
external groups in a direct and diplomatic way while able to hold
ground without damaging relationships and minimizing noise--
- Track record of recruiting exceptional talent, building high
performing teams to include managing, mentoring and motivating
employees
- Strong Communication (oral/written) to included strong
presentation skills, including ability to communicate in small and
large settings and with senior level management, regulatory
agencies and physicians
- Strong analytical and business skills; with the ability to
communicate effectively at all levels within the organization and
clinical sites
- Demonstrated ability to process complex information and
summarize it concisely in writing and/or verbally in a professional
manner
- In depth understanding of healthcare, device, and biotechnology
industry issues
- Highly collaborative and desire to reach across the
organization to understand needs and how to meet those needs.
- Computer skills: Microsoft Office Suite - Word, Excel and
PowerPoint, Adobe Acrobat Pro Preferred Qualifications:
- Experience training to both medical device product and clinical
protocol execution.
- Knowledge of clinical methodology and application in clinical
protocol development. Experience and Education Requirements:
- Typically requires a Bachelor's degree (preferably in life
sciences, biomedical engineering, biostatistics, health care or
similar field)--
- Advanced degree preferred (e.g., Masters, PhD, MD, etc).
- 17+ years of industry experience. 13+ years of years of
successful leadership experience in relevant industry.
- Minimum of 5 years of people management experience. Travel
Required:--
- Up to 30% Functional Description: Management Oversees the
direction, planning, execution, and interpretation of clinical
trials research, data collection activities and clinical
operations. Establishes and approves scientific methods for design
and implementation of clinical protocols, data collection systems
and final reports. Support new and ongoing clinical research and
clinical trials and ensure efficient and timely processing of
confidentiality agreements and clinical agreements. Monitors
adherence to protocols and determines study completion. Manages
clinical and regulatory files and maintains clinical inventory
intended for distribution to investigational sites. May interact
with investigational sites, clinical consultants, Contract Research
Organizations and other vendors. Selects, develops and evaluates
personnel to ensure the efficient operation of the function.
Functional/Business Knowledge:
- Possesses in-depth knowledge of the leading practices of a
functional area and familiarity with several others.
- Fully understands and translates organization, business
strategies, and company's goals to functional priorities. Scope:
- Makes final decisions on administrative or operational matters
and ensures effective achievement of objectives.
- Interacts internally and externally with others, requiring
negotiation of extremely critical matters.
- Recognized as an influential leader throughout the
organization. Judgement:
- Consistently works with abstract ideas or situations across
functional areas of the business.
- Thorough assessment of factors, identifies and evaluates
fundamental issues, providing strategy and direction.
- Erroneous decisions will have a long-term effect on the
company's success. Management:
- Effectively able to operate in complex or matrix
environment.
- Directs and controls the activities of one or more functional
areas, divisions, product groups or service areas through senior
managers who have overall responsibility for the successful
operation of those assigned areas. An Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and
will not be discriminated against on the basis of disability. If
you are an individual with a disability and would like to request a
reasonable accommodation as part of the employment selection
process, please contact Talent Acquisition
at--talentacquisition@dexcom.com .-- To all Staffing and Recruiting
Agencies: Our Careers Site is only for individuals seeking a job at
Dexcom. Only authorized--staffing and recruiting agencies may use
this site or to submit profiles, applications or resumes on
specific requisitions.--Dexcom does not accept unsolicited resumes
or applications from agencies. Please do not forward resumes to the
Talent Acquisition team,--Dexcom employees or any other company
location. Dexcom is not responsible for any fees related to
unsolicited resumes/applications. Get Matched Upload Your Resume To
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Spending Accounts 401(k) program Employee Stock Purchase Program
(ESPP) Telehealth and Employee Assistance Programs Our Philosophy
Dexcom empowers people to take control of diabetes. We focus on
enabling better outcomes for patients, caregivers and clinicians by
delivering solutions that are best in class-defined as being
dependable, simple and essential to taking control of diabetes. We
are committed to revolutionizing diabetes care by seeking out and
solving the needs of our employees, collaborators and community.
Listen Comprehend the needs of people affected by diabetes. Serve
with integrity Act in the best interest of our community. Think big
Use technology to revolutionize diabetes care. Inspire confidence
within our community and in one another. Jordan Morris The Dexcom
Continuous glucose monitoring (CGM) System helps Jordan eliminate
surprise highs or lows when he's about to go out on the field.
Keywords: Dexcom Inc., San Diego , Senior Director Clinical Affairs, Healthcare , San Diego, California
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