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.
Essential Position Duties:
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.
- Understands client needs: Defines the engagement through application of expertise in quantitative and/or qualitative research methods. Advises on best methods for meeting project objectives as well as those that will not meet client goals. Ensures that project deliverables are of high scientific quality.
- Regulatory Strategy: Apply knowledge of regulatory requirements and guidelines to help clients develop regulatory submissions, prepare for regulatory meetings and attend regulatory meetings with clients if requested.
- Develop and maintain Client Relationships: Meet with clients as needed to discuss project progress, review findings and direction of research, confirm needs, ensure quality deliverables, escalate issues as required. Consider and suggest additional work to support client needs.
- Market and Sell Services: Contact and call on potential clients to explain the capabilities of Covance in collaboration with Sales and Marketing. Find opportunities to refer business to other groups or business units within Covance.
- Prepare Proposals: Review and revise draft proposals and budgets in response to client requirements following standard formats.
- Direct Project Teams: Direct study teams in executing projects, including mid-level and junior staff. Set expectations, guide activities, manage and mentor staff as needed.
- Manage Project Deliverables: Reviews and revises written memos, correspondence, and reports; conducts in-person presentations for clients. Manage internal timelines to ensure that deliverables meet client timelines.
- Manage Project Financial Health: Manage project budget and internal staff hours to not exceed contracted budget. Manage scope creep or out of scope work. .
- Lead and Manage Staff: Assumes leadership role in the firm, playing an active role in the setting of firm policies. Acts as an advisor to less experienced consulting staff, orienting them on firm policies and career development objectives.
- Provide Leadership: Work within the consulting division, and across CMA, to participate in strategic discussions and set strategic direction.
- Scientific Expertise: Develops and presents internal scientific trainings. Actively supports development of new service offerings
- Process: Continuously evaluate processes and areas for improvement, leading development of new process.
- The Patient Reported Outcomes Director typically holds a graduate degree (preferably doctoral level) in health services research, research psychology, public health, clinical science or other relevant discipline from an outstanding program at a distinguished university.
- Ten or more years of direct and industry-related experience relating to the position duties.
- Extensive knowledge of the drug development process and familiarity with international regulatory requirements
- Demonstrated ability to establish new and maintain existing client relationships
- Good understanding of the healthcare / life sciences consulting environment
- Demonstrated people management experiencepreferred
- Up to 30%.
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.