Director--Patient Centered Assessment - Remote US based

Company: Labcorp Drug Development - USA
Location: Gaithersburg
Posted on: March 20, 2023

Job Description:

Director, Patient Centered Assessment Remote Job Description Labcorp Drug Development seeks a renmote / home based senior-level researcher who specializes in patient-reported outcomes and clinical outcomes assessments to develop business, lead client engagements and manage client relationships in our consulting group. The Director leads expert teams (colleagues and clients) to conduct scientifically robust qualitative and quantitative studies, develop and validate COA measures, assist in implementing COAs in clinical trials to measure patient relevant endpoints, develop and implement FDA COA related strategy and develop publications and present at scientific conferences. A specific background in COA development and validation and application of COAs in clinical trials is desired. This is a unique opportunity to work with clients in a scientific consulting capacity and build and grow an expert team, including: taking scientific responsibility for project completion, applying regulatory knowledge/expertise; attending meetings with clients, identifying opportunities for new business; leading projects and overseeing project teams, budgets and deliverables; developing and leading staff; and acting as resource for scientific COA knowledge internally. Job Responsibilities and skills: The candidate will be able to: Provide scientific leadership including applying COA regulatory knowledge/expertise with clients and internal colleagues Direct project teams, setting expectations, guiding activities, managing and mentoring staff Attend and lead client meetings for current and new projects Prepare proposals and budgets (conceptualize, draft, revise, supervise preparation of) in response to client requirements Advise on best methods to address client and research needs Manage their capacity and utilization across multiple projects Participate in business development including capabilities pitches and bid defenses Interact effectively with internationally remote and culturally diverse colleagues Effectively coach and mentor junior colleagues Produce deliverables (e.g. study protocols, reports) of high scientific quality Present scientific work in peer-reviewed journals and at professional meetings The ideal candidate will have a solid understanding of advanced design and analysis techniques used in both qualitative and quantitative COA research, including ability to: Critically review literature, COA measures and labels, conduct evidence gap analyses Develop COA measures using qualitative and quantitative research methods Design statistical analysis plans for COA endpoints in clinical trials including estimation of meaningful within-patient change Analyze and interpret data using advanced statistical methods Conduct psychometric analyses using modern validity theory Advise clients on regulatory strategy related to COAs used in medical product development Recommend appropriate COA measures for inclusion in clinical trial protocols. The candidate will offer experience in a consulting or pharma/biotech environment and have experience in clinical trial and observational study design, selection of COAs to measure clinical trial endpoints, development of study protocols and analysis plans, collection and analysis of qualitative and quantitative data, and with COA measure development and evidence generation to support labeling claims in the US and EU. The candidate must possess skills in and experience consulting for pharma and biotech clients and the ability to clearly communicate both verbally and written. At Labcorp Drug Development, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in our impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. Labcorp Drug Development believes that their best-in-class employees deserve first-class benefits. Labcorp Drug Development offers an outstanding benefits package including medical & dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, short and long-term disability, and life insurance, all of which are effective on your first day of employment! At Labcorp Drug Development, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us! Education/Qualifications The candidate will possess a doctorate degree in a relevant field (e.g. psychology, educational psychology, health services research). Experience The Director should have at least 10 years of experience working with biopharmaceutical and/or medical device companies and have: solid understanding of advanced methods and analytic techniques used in qualitative and quantitative research related to COA development and validation experience interacting with regulatory agencies related to COA labeling claims and evidence requirements. ability to establish new and maintain existing client relationships people management experience The Director is expected to travel to meet with clients and must be able to work on evenings and weekends as necessary to meet project schedules. EEO Employer LabCorp Drug Development 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. Pay Range: $165,000 - $195,000 USD Position may be eligible for bonus and RSU, dependent on employee and company performance Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here . As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries. Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023. We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement .

Keywords: Labcorp Drug Development - USA, Washington DC , Director--Patient Centered Assessment - Remote US based, Executive , Gaithersburg, DC