Summary of Major Responsibilities
The Senior Director of Sponsored Research is responsible for sustaining and developing research collaborations between Exact Sciences and other research institutions, including but not limited to academic, industry, government and non-profit organizations. This role will be responsible for scientific leadership in the development and execution of the company's precision oncology and cancer screening strategies; including, but not limited to, the design and implementation of next-generation sequencing (NGS) and other multi-OMIC based assays focused on the development, validation, and regulatory approval of diagnostic tests designed to help detect cancer early, determine the most appropriate therapies for patients, monitor therapy effectiveness, and detect the presence of residual disease.
The primary objective is to create collaborative and sustained relationships that will advance the overall mission of Exact Sciences. The Senior Director of Sponsored Research will be both a leader and participant on internal cross-functional program teams and working groups; including, but not limited to, members of the business development, research and development, pathology, biostatistics, clinical operations, medical affairs, and commercial teams. This position will provide scientific leadership across multiple external research programs.
The position will require at least 30% of travel time and will focus on developing external relationships with leaders in academic oncology, cooperative trial groups, and research organizations, as well as identify investigators and sites to participate in clinical trials. The Senior Director of Sponsored Research will interact with clinical and scientific leaders in pharma, biotech and academia, along with key opinion leaders and other third parties. Most importantly, this position will be responsible for the design, drafting, review, interpretation, and leadership in the execution of sponsored research and reporting of key study results in the scientific literature or scientific conferences together with collaborators. The role will require experience in contracting, writing research proposals, designing study plans, executing sponsored research agreements, budgeting for projects, and writing or contributing to peer reviewed publications.
This role will interact closely with members of the Academic and Network Collaborations team within Pipeline as well as medical affairs, clinical and regulatory affairs, biostatistics, R&D, and commercial to cultivate relationships with leading academic medical centers, and cancer prevention networks, negotiating collaboration agreements, and ensuring that those collaborations deliver against contract expectations.
Essential Duties and Responsibilities
• Work with the Academic and Network Collaborations team to identify the global clinical sample provision market and systematically identify key institutions or networks that can help Exact Sciences meet its research and sample acquisition goals.
• Develop the overall scientific sponsored research strategy; including, but not limited to, minimal residual disease, therapy selection, and cancer screening in partnership with internal and cross-functional stakeholders, commercial, pipeline, compliance, and regulatory.
• Establish a trusted partner relationship with senior most leaders of key academic institutions, health systems and professional cancer prevention networks.
• Collaborate with Exact Sciences' cross-functional team members from the research and development, pipeline, and commercial organizations to participate in and provide scientific expertise to the formulation of commercialization strategy and the creation of product profiles for new products and services.
• Participate on study teams in the development of clinical protocols required to support product development, validation, and commercialization; including, but not limited to, the adoption and development of novel approaches for the demonstration of clinical validation and utility.
• Engage with clinical and scientific leaders within precision and molecular medical and surgical and radiation oncology to gain a greater understanding of key clinical questions in patient management, requisite a new generation of clinical tool needs, and facilitate their understanding of the scientific validity and clinical utility of Exact Science's products.
• Accountable for scientific presentations and publications generated as a result of sponsored research collaborations.
• Coordinate closely with the Medical Affairs team to drive key KOL engagement at priority institutions.
• Maintain deep familiarity with clinical study protocols and operational plans as well as progress against patient recruitment and sample acquisition goals; Actively engage in improving performance at institutions as needed.
• Attend off site-meetings and conferences as needed to build and solidify relationships.
• Conduct all activities in an ethically and legally compliant manner.
• 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.
• Invest in developing talent to meet both career goals and the organizations goals.
• Build strength-based teams; apply diverse skills and perspectives to achieve current and future business needs.
• Deep familiarity and/or experience with clinical study development, site recruitment, and site management.
• Knowledge of the US healthcare system and institutions; strong external relationships in the US.
• Ability to partner with decision makers, such as health system administrators, leading physicians, clinical researchers, and strategic C-Suite level leaders.
• Ability to comprehend key research and clinical priorities and communicate them to potential partners.
• Demonstrate problem-solving and interpersonal skills; Must have a 'can-do' attitude and a strong desire to take ownership of many different relationships and projects.
• Strong desire to join a rapidly-growing company and work in a fast-paced environment.
• Ability to work independently and manage multiple timelines, while maintaining the team focus.
• Strong leadership skills with geographically dispersed teams.
• 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.
• Regular and reliable attendance.
• Ability to work nights and/or weekends.
• Apply strong analytical skills.
• Apply strong communication skills; ability to create and maintain open, clear, and collaborative communication with internal stakeholders, senior management, external partners and customers, and key opinion leaders.
• Ability to travel up to 30% of working time away from work location, may include overnight/weekend travel.
• Ph.D. in Life Sciences or related field.
• 20+ years of experience in academic or biotech industry in pharmaceutical or diagnostics industry, Medical Affairs or relevant commercial experience with appropriate scientific acumen in Oncology.
• Demonstrated expertise in molecular oncology.
• Demonstrated ability to lead cross-functional internal and external teams of professionals focused on complex, multi-faceted projects.
• Familiarity with laboratory analytical process development and biostatistics.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.
• 10+ years of experience in developing and securing strategic health care institution collaboration relationships, preferably with a CRO or other medical devices/diagnostics/pharmaceutical company.
• Strong knowledge of FDA and Ex-U.S. regulatory documentation and processes.
• 8+ years of experience in managing sponsored research or similar type programs.
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.