Associate Director, Clinical and Regulatory Program Management
Company: Exact Sciences Corporation--
Posted on: February 25, 2021
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Exact Sciences is an equal employment opportunity employer. All
qualified applicants will receive consideration for employment
without regard to age, color, creed, disability, gender identity,
national origin, protected veteran status, race, religion, sex,
sexual orientation, and any other status protected by applicable
local, state or federal law. The Company's affirmative action
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Sciences - Associate Director, Clinical and Regulatory Program
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in! Associate Director, Clinical and Regulatory Program Management
Job Locations US-WI-Madison - US-Remote Req No. 2021-7361 Category
Clinical Operations Type Regular Full-Time Summary of Major
Responsibilities The Associate Director, Clinical and Regulatory
Program Management is a leader within the Clinical and Regulatory
Affairs organization, responsible for leading a clinical study
portfolio execution strategy in support of Exact Sciences
commercial and/or pipeline products. This includes cross functional
partnership with the business unit product leads, Clinical
Development, Clinical Operations, Data Management, Biostatistics,
Regulatory Affairs, and other enabling functions to ensure that
clinical study execution is successful in meeting the product
development and evidence generation needs. This role will be
accountable to develop the operating norms for the role,
development of a team to support the needs of the business and
facilitate change management with the introduction of this
function. This position ensures successful integration and
communication between multiple projects. This is a hands-on role
that requires close collaboration with the Senior Leadership level
across Exact Sciences. Essential Duties and Responsibilities
- Build and lead clinical program roadmaps to support product
development and evidence needs to include formulating, organizing,
and monitoring inter-connected clinical studies and projects.
- Establish operating norms for the program management team to
include standard tools for tracking, communications, and metrics,
that can be repeated across programs.
- Build clinical and regulatory affairs program management team
in alignment with business needs.
- Act as a function representative on product core teams or
workstream teams as appropriate.
- Develop cross-functional business relationships with pipeline
product leads, Clinical Development, Clinical Operations, Medical
Affairs, Research and Development, and others as appropriate.
- Partner with functional people leaders to identify resource
needs, activity timing, and systems support to ensure delivery of
- Identify process gaps, overlaps, and inefficiencies and take
initiative to lead improvement efforts.
- Develop schedules, budgets, risk management plans, quality
goals, and lead the team to success.
- Exercise judgment and determine appropriate action to a variety
of problems of varying complexity.
- Create and maintain detailed program metrics around initiative
goals and communicate progress to key stakeholders.
- Synthesize complex process and issues and organize, present,
and convey them to leadership.
- Manage multiple priorities and deadlines for various
stakeholders in a cross-functional matrix environment.
- Motivate and lead teams of cross-functional resources in a
matrixed organization with competing priorities, with or without
direct authority or reporting relationships.
- Supervise staff; including, but not limited to, organize and
prioritize work, write/conduct performance reviews, train/develop,
and manage work performance.
- Communicate--goals so employees understand them and their role
in achieving them.
- Motivate--and--inspire--employees to do their best work through
- Maintain--morale and support employee engagement
- Adaptable to rapid changes in priorities, strong sense of
urgency, and able to identify ways to work together to achieve
results needed for all requests.
- Strong verbal and written communication skills.
- Strong documentation skills and attention-to-detail necessary
in a GCP environment.
- Effective presentation skills.
- Ability to exercise judgment and determine appropriate action
to a variety of problems of varying complexity.
- Excellent analytical, problem solving, and decision-making
- Uphold company mission and values through accountability,
innovation, integrity, quality, and teamwork.
- Support and comply with the company's Quality Management System
policies and procedures.
- Attend work regularly and reliably.
- Ability to work designated schedule.
- Ability to work nights and/or weekends as needed.
- Ability to lift up to 10 pounds for approximately 5% of a
typical working day.
- Ability to work on a mobile device, tablet, or in front of a
computer screen and/or perform typing for approximately 90% of a
typical working day.
- Ability and means to travel between Madison locations.
- Ability to travel 10% of working time away from work location,
may include overnight/weekend travel. Qualifications Minimum
- Bachelor's degree in a health, medical, or field related to
essential duties of this role.
- 10+ years of experience in life sciences, biotechnology,
diagnostics, pharmaceutical, medical device, or field related to
essential duties of this role.
- 5+ years of project and/or program management experience.
- 3+ years of direct people leadership experience.
- Demonstrated ability to work in a matrix management
organization with primary responsibility for project success while
relying on a team of resources which are not direct reports.
- Demonstrated ability to balance cost, quality, and schedule
constraints while escalating issues.
- Demonstrated ability to prioritize and balance multiple
competing priorities within and across multiple projects at the
- Demonstrated ability to work with 21 CRF Part 11 compliant
sample tracking software.
- Moderate proficiency with Microsoft Office Project as well as
Visio, Excel, and PowerPoint.
- Authorization to work in the United States without
- Demonstrated ability to perform the Essential Duties of the
position with or without accommodation. Preferred Qualifications
- Strong understanding of FDA regulations and ICH GCP.
- Strategic planning experience.
- Good understanding of global regulations.
- Good understanding of clinical systems functionality and
- PMI Project Management certification. #LI-MF1 We are an equal
employment opportunity employer. All qualified applicants will
receive consideration for employment without regard to age, color,
creed, disability, gender identity, national origin, protected
veteran status, race, religion, sex, sexual orientation, and any
other status protected by applicable local, state or federal law.
Applicable portions of the Company's affirmative action program are
available to any applicant or employee for inspection upon request.
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Keywords: Exact Sciences Corporation--, Madison , Associate Director, Clinical and Regulatory Program Management, Executive , Madison, Wisconsin
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