Associate Director, Clinical and Regulatory Program Management

Company: Exact Sciences Corporation--
Location: Madison
Posted on: February 25, 2021

Job Description:

Exact Sciences values its current relationships with external recruitment vendors. If you are interested in learning more about partnering with us as an external recruitment vendor, please contact our Human Resources Department directly. Neither Exact Sciences Corporation nor any subsidiary or other related entity will be liable for any fees for any candidate submitted without a binding written search agreement. For example, written (including email) or verbal contacts with any person within or outside of Exact's Human Resource Department are inadequate, in the absence of a binding written agreement, to bind either Exact Sciences Corporation or any subsidiary or related entity to any obligation to retain the services of, or to pay any fee to, any recruiter. 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 program is available to any applicant or employee for inspection upon request. If you need any assistance seeking a job opportunity at Exact Sciences, require a reasonable accommodation with the application process or would like to share feedback about the recruitment process, please call our Recruitment Coordinator at 608-535-8726 or email jobs@exactsciences.com. Careers - Exact Sciences - Associate Director, Clinical and Regulatory Program Management Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Welcome page Returning Candidate? Log back 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 program goals.
• 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 coaching.
• Maintain--morale and support employee engagement initiatives.
• 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 skills.
• 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 Qualifications
  • 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 same time.
  • 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 sponsorship.
  • 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 requirements.
    • 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. Options Apply for this job online Apply Share Email this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading...
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Keywords: Exact Sciences Corporation--, Madison , Associate Director, Clinical and Regulatory Program Management, Executive , Madison, Wisconsin