Clinical Compliance Director
Company: Exelixis
Location: King Of Prussia
Posted on: April 20, 2024
Job Description:
SUMMARY/JOB PURPOSE: Ensures risk management, issue management,
and risk/issue monitoring are implemented and embedded across their
responsible trial portfolio and functional areas of focus. Ensures
clinical research activities are conducted by clinical staff in
accordance with ICH GCP, relevant international and local
regulations, requirements, and guidelines. Partners with quality
assurance (QA) teams and other functional groups across PDMA to
execute inspection readiness, risk management, oversight of quality
performance metrics, and issue escalation of quality issues. The
Director provides Good Clinical Practice (GCP) guidance and
best-practice expertise to facilitate optimal clinical trial
execution compliance management as it relates to Process Deviations
and CAPA management to and ensure study adherence to applicable GCP
regulations throughout all phases of clinical development.ESSENTIAL
DUTIES AND RESPONSIBILITIES:
- As part of Clinical Compliance and Risk Management (CCRM) Team,
represent Development Operations and collaborate with Quality
Assurance on compliance-related activities, processes and
functions
- Support Development Operations functions and Clinical Study
Delivery Teams to maintain readiness, prepare for, and participate
in regulatory agency inspections and Quality audits
- Display active leadership as it relates to Development
Operations management of process deviations, audit and inspection
findings, and CAPAs
- Manage and track Development Operations internal and external
audit responses. Support input and the review of investigator,
vendor, process and system audits to ensure responses are complete
and provided in a timely manner
- Manage and track Development Operations and Vendor assigned
CAPAs validation, processing and resolution to ensure on time
closure. Translate and facilitate with functional area partners an
outcome to defined process, study plans or training updates
- Ensure inspection readiness, review periodically the outcomes
of risk management/ management monitoring; escalate to appropriate
governance and adapt accordingly
- Collaborate with cross functional teams to identify compliance
program risks and mitigation strategies
- Establish and maintain CCRM key performance indicators, and
metrics tools that interfaces with Quality Assurance representing
the state of compliance for Development Operations
- Create and lead CCRM initiatives and infrastructure that drive
compliance
- Collaborate with CCRM team members to ensure achievement of
corporate and department goalsSUPERVISORY RESPONSIBILITIES:
- NoneEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- BS/BA degree in related discipline and a minimum of 13 years of
related experience; or,
- MS/MA degree in related discipline and a minimum of 11 years of
related experience; or,
- PhD in related discipline and a minimum of 8 years of related
experience; or,
- Equivalent combination of education and experience.
- May require certification in assigned area.Experience/The Ideal
for Successful Entry into Job:
- Typically requires a minimum of 16 years of related experience
or the equivalent combination of experience and
education/training.
- Typically requires a minimum of 12 years of
pharmaceutical/biotechnology/CRO in quality management of clinical
trials, training, clinical operations, project management.
- Advanced knowledge of ICH-GCP guidelines and applicable drug
development regulations.
- Experienced in leading inspection readiness activities
- Experienced in leading the development of SOPs and other
process related documentation.
- Experienced in supporting clinical trial GCP compliance/quality
management activities.
- Strong understanding of drug development and clinical trial
execution, including other required functional areas involved in
clinical trials.
- Strong working knowledge of Clinical Risk Management and
Mitigation strategies.Knowledge/Skills:
- In-depth knowledge of biopharmaceutical industry regulations,
standards and best practices.
- Poise and confidence to provide verbal and written
communications and formal presentations toExelixis; and external
vendors; executives, senior management, functional management and
individual contributors.
- Must be a self-starter, quick learner, strong collaborator and
team player with ability to work independently with minimal
supervision.
- Must have excellent analytical, strategic thinking,
problem-solving, time management, changemanagement and
organizational skills with demonstrated ability to work in a
fast-paced environment andadapt to changing business plans and
priorities.
- Strong interpersonal, verbal and written communication
skills.
- Strong attention to detail.
- Ability to identify and communicate issues and risks.
- Excellent presentation skills.
- Ability to build and maintain strong relationships.
- Ability to influence without direct authority.
- Excellent computer skills, including advanced knowledge of
Microsoft Excel, Word, PowerPoint and Outlook.
- Embraces Exelixis core values: Be Exceptional; Excel for
Patients; Exceed Together.JOB COMPLEXITY:
- Applies judgement and professional expertise in new
situations.
- Independent team member performing highly technical or
specialized work.
- Responsible for executing a risk and issue management
framework.
- Responsible for executing inspection readiness for clinical
trial teams.WORKING CONDITIONS:
- May include occasional business travel (less than 10%)
- 5 Day onsite office presence#LI-JD1If you like wild growth and
working with happy, enthusiastic over-achievers, you'll enjoy your
career with us!Our compensation reflects the cost of labor across
severalU.S. geographic markets, and we pay differently based on
those defined markets. The base pay range for this positionis
$174,000 - $248,500 annually. The base pay range may take into
account the candidate's geographic region, which will adjust the
pay depending on the specific work location. The base pay offered
will take into account the candidate's geographic region,
job-related knowledge, skills, experience and internal equity,
among other factors.In addition to the base salary, as part of our
Total Rewards program, Exelixis offers comprehensive employee
benefits package, including a 401k plan with generous company
contributions, group medical, dental and vision coverage, life and
disability insurance, and flexible spending accounts. Employees are
also eligible for a discretionary annual bonus program, or if field
sales staff, a sales-based incentive plan. Exelixis also offers
employees the opportunity to purchase company stock, and receive
long-term incentives, 15 accrued vacation days in their first year,
17 paid holidays including a company-wide winter shutdown in
December, and up to 10 sick days throughout the calendar
year.DISCLAIMERThe preceding job description has been designed to
indicate the general nature and level of work performed by
employees within this classification. It is not designed to contain
or be interpreted as a comprehensive inventory of all duties,
responsibilities and qualifications required of employees assigned
to the job.We are an Equal Opportunity Employer and do not
discriminate against any employee or applicant for employment
because of race, color, sex, age, national origin, religion, sexual
orientation, gender identity, status as a veteran, and basis of
disability or any other federal, state or local protected
class.
Keywords: Exelixis, Cherry Hill , Clinical Compliance Director, Healthcare , King Of Prussia, New Jersey
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