Patient-Reported Outcomes Director
Gaithersburg, MD or Home-Based in the US
Are you ready to discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in patients’ lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative work place, along with access to comprehensive benefits. Your work is meaningful and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
Covance Market Access (CMA) consulting provides a broad suite of services designed to assist our clients in improving patient health by facilitating access to medical innovations. Our Patient reported Outcomes (PRO) team, a division of HEOR within CMA, is rapidly growing due to increased business across Covance’s clinical trial offerings.
We are seeking Patient Reported Outcomes Director who specializes in patient-reported outcomes and clinical outcomes assessments to lead client engagements and take scientific responsibility for project completion and oversee all aspects of project execution including study teams. Responsibilities include strategic consultation and understanding of the best methods to address research needs, oversee multiple projects over extended time horizons, and actively participate in marketing and sales including client development and relationship management.
Must have a Ph.D. and at least 10 years of experience in Patient Centered Research, Patient Reported Outcomes in clinical and observational studies, psychometric validation studies, and/or Global Outcomes along with experience in Regulatory and with the FDA (Submissions and Labeling) and peer-reviewed PRO publications. Solid understanding of advanced design and analysis techniques used in both qualitative and quantitative research including reviewing literature; PRO instruments and labels; gap analysis; questionnaires and expert and patient interviews; and statistical analysis plans for PRO and COA. Experience and expertise in clinical trial study design; selection of screening tools; development of study protocols and statistical analysis plans; collection of study data; and instrument development to support labeling claims is essential.
This is a unique opportunity to build and expand the team and work with clients in a scientific consulting capacity including regulatory knowledge/expertise; attend meetings with clients for current and new relationships and identify opportunities for new business; directs project management with overseeing the project management teams, budgets and deliverables; and develops and leads staff and acts as a resource for scientific knowledge internally and for strategic purposes.
The Director leads client engagements and takes scientific responsibility for project completion and oversees all aspects of project execution including study teams. He/she is responsible for strategic consultation and for use of the best methods to address research needs. The Director is able to oversee multiple projects over extended time horizons. He/she actively participates in marketing and sales including client development and relationship management.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.