Director, Research and Development, MRD

Summary of Major Responsibilities
The Director, Research & Development works on multiple projects that are extremely complex in scope. As a thought leader, the Director, Research & Development brings knowledge and expertise to bear in planning, design, and execution to ensure successful and timely completion of large or complex projects. This position is responsible for providing the timeline, plan, and successful completion for assignments/projects. This position also plays a critical role in the analysis, interpretation, and presentation of data and provides data driven outcomes to senior management. This role is responsible for leading, directing, managing, executing, and completing projects associated with developing new technologies, new products, or improving existing products. This position provides clear leadership to the team by working to define clear and realistic goals, clearing barriers to success, developing a general management view of the project and how it fits into the strategic landscape. This position has a clear understanding of all the skills and tasks associated with successful project execution, which are complex in scope. This position exercises judgment and makes informed decisions using broadly defined practices and procedures to determine appropriate action or in selecting methods, techniques, and evaluation criteria for obtaining solutions. This position is also responsible for supporting a collaborative environment that promotes positive teamwork where all members are working for the good of Exact Sciences.

This Director, R&D position will provide technological and scientific leadership for Exact Sciences' minimal residual disease (MRD) product development program.
Essential Duties and Responsibilities

• Provide leadership, technical guidance, and mentorship to a team of research associates and scientists.
• Work on significant and unique issues where analysis, situations, or data requires an evaluation of intangible variables and may impact future concepts, products, or technologies.
• Develop, plan, and analyze results of comprehensive advanced research experiments within several product or technology areas within defined timelines; effectively present and clearly communicate findings at data meetings, group meetings, and project team meetings to determine the next steps and the path forward for successful outcomes.
• Act independently to determine methods and procedures or technologies on new assignments and provide ideas for new techniques and methods.
• Exercise latitude in determining objectives and approaches to critical assignments.
• Provide clear and direct leadership to assigned project teams and foster a culture of teamwork.
• Maintain knowledge of technological industry developments; provide technical assessment and guidance when evaluating or developing technologies, methods, and procedures.
• Provide deep scientific leadership and technical input and participate in decisions affecting project planning and experimental design.
• Prepare, provide, and present information and data for scientific abstracts, and industry conferences, project meetings, or publication.
• Prepare manuscripts of major findings and research outcomes for review and publication.
• Perform complex analyses and present results and data driven outcomes to senior management, as well as to a variety of audiences throughout the organization.
• Contribute to the intellectual property portfolio by implementing innovative and creative ideas to solve problems or improve on current methods.
• Help with IP disclosures and assist in answering questions related to IP filings.
• Generate, document, and communicate development plans for critical projects.
• Prepare, review, and approve detailed technical procedures, protocols, and reports.
• Evaluate impact of nonconforming data to product or process.
• Prepare reports and documentation and provide highly technical analysis or summarization of experimental results, outcomes, next steps, and provide future direction of the project to functional leader, technical teams/groups, or project teams.
• Present experimental results and defend scientific ideas and findings at project or departmental meetings; critically evaluate scientific data for its merits; lead meetings and help provide directions as a subject matter expert.
• Work on problems which are extremely complex in scope in which analysis of data requires an evaluation of intangible variables.
• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.
• Responsible for the key phases of product development.
• Train techniques and procedures to junior research associates and scientists.
• Ability to develop formal networks with key decision makers, internally and externally.
• Apply deep scientific expertise, innovation, creativity, and collaboration with others and independent thought.
• Communicate clearly and frequently with all levels of the organization; including team members, project team members (core and extended), functional managers, clinical lab, and other stakeholders.
• Create and deliver high quality presentations that effectively communicate and tie into a cohesive story the project status and/or experimental results.
• Gather input from collaborators, partners, team members and suppliers to define goals and establish a strategy to meet those goals.
• Contribute in-depth, technical knowledge to improve staff capabilities.
• Participate in technical decisions, identify problems, investigate alternatives, and recommend possible courses of action.
• Contribute ideas for new product initiatives, troubleshooting, and root cause analysis.
• Ensure team lab notebooks are completed properly following all legal, ISO and QSR requirements.
• Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicate goals clearly to employees to ensure understanding and success in achieving them.
• Motivate and inspire employees to do their best work through coaching.
• Maintain morale and support employee engagement initiatives.
• Apply qualitative and analytical skills with strong attention to detail.
• Ability to effectively work on several varied projects at one time, with frequent changing priorities.
• Excellent analytical, problem solving, and decision-making skills.
• Exercise technical proficiency, scientific creativity and rigor, and independent thought when challenging and debating scientific ideas.
• Apply sound technical ability and knowledge.
• Apply experimental knowledge and outcomes to new and valuable problems; ability to make predictions based on a deep understanding of the fundamental nature of the inputs into a decision or action.
• 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.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• 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 to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel 15% between Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

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Qualifications
Minimum Qualifications

• Ph.D. in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position; or Master's degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position and 4 years of related experience in lieu of a Ph.D.; or Bachelor's degree in life sciences, medical technology, clinical laboratory science, chemical/physical/biological science, or field related to the essential duties of the position and 6 years of related experience in lieu of Ph.D.
• 12+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• 10+ years of industry experience in biology and/or chemistry.
• 4+ years of direct people leadership and management experience.
• Demonstrated thought leader in the principles of molecular biology, biochemistry, next-generation sequencing (NGS), genomics, and/or protein research.
• Demonstrated leadership in the area of product/assay research, design, or development.
• Thorough knowledge of molecular biology, cell biology, next-generation sequencing (NGS) and related sciences.
• Proficient in Microsoft Office to include Excel, Word, and PowerPoint.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 15+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• Previous experience as a project lead for a team of scientists.
• Previous experience working in a molecular diagnostics/clinical laboratory setting.
• Previous industry experience in product development or technical support.
• Experience in PCR and molecular biology.
• Experience with genomic databases and software.
• Experience in a pharmaceutical or biotech manufacturing environment; preferably in a GMP and/or ISO environment.
• Working knowledge of FDA submissions, regulations, and procedures.
• Demonstrated knowledge of DNA/RNA purification.
• Background containing a substantial amount of laboratory work including troubleshooting.
• Experience developing products that assay cfDNA, especially in the cancer setting.
• Expert in targeted Next Generation Sequencing (NGS) sample preparation strategies.
• Experience with multiplex PCR technologies.
• Familiarity with bioinformatics approaches to NGS data analysis.

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.
Job Summary

• Req No.: 2021-9482
• Category: Research & Development
• Type: Regular Full-Time