PhiladelphiaRecruiter Since 2001
the smart solution for Philadelphia jobs

Director VEO PCO

Company: Robsco Search
Location: Philadelphia
Posted on: October 13, 2019

Job Description:

DIRECTOR VEO PCO Are you looking for an opportunity to apply specialized expertise in Patient Reported Outcomes (PRO) /Clinical Outcome Assessments (COA) in oncology drug development? Our client is seeking a Director, PRO/COA with experience in Oncology. In this role, you will ensure that the patient's voice is included in product development and will have the opportunity to develop novel innovative endpoints that inform technical success in drug development, facilitate market access. You will also be responsible for development of PRO/COA endpoint strategies, and development and validation of PROs to support registration, reimbursement and differentiation of client assets in development. The Patient-Center Outcomes (PCO) team provides consultancy and scientific expertise to support internal stakeholders in Clinical, Regulatory, Value Evidence and Outcomes and Patient Engagement. The PCO team is also involved in external initiatives to support clients expertise in patient engagement, measurement and novel endpoint development to inform treatment benefit including CPATH, NIH, ISOQOL and PCORI). The PCO team is a global multidisciplinary group including Health Outcomes Researchers, Epidemiologists, Clinical Scientists and statisticians. In this role you will lead the development of global measurement strategies such as Patient-Reported Outcomes (PROs) and Clinician Reported Outcomes (ClinROs) for multiple molecules within an actively growing Oncology protfolio. As a Director of Oncology PRO/COAs, you should be recognized in the field of outcomes research with experience in the pharmaceutical industry or regulatory environment, and may include experience in contract research organizations or academic settings. Your role will be exciting and varied as you will be involved in a range of responsibilities. These include establishing and leading PCOR disease area strategies that support establishment of humanistic impact of a condition and its treatment on patients and caregivers; reviewing, modifying or developing conceptual models and developing hierarchical endpoint models. You will be responsible for assessing whether instruments are Fit-for-Purpose with attention to content validity and psychometric properties specific to context of use. You will make strategic recommendations to address any gaps in evidence support a PRO/COA for regulatory submissions, and develop and support research to develop qualitative and quantitative evidence of a PRO/COA as fit for purpose and leading to PRO Dossiers. You will define endpoint strategies, author PRO/COA sections of protocols and analysis plans, and support interactions with regulators with respect to PRO/COA endpoints. In this role, you will be responsible for managing vendors including work development, contract initiation, project milestones, timelines, deliverables, and budgets. You will need to have excellent communication and project management skills to develop professional relationships that will enable you to act as PCOR functional lead in cross-functional teams to establish needs and develop PCOR strategies. Your strong leadership skills will enable you to successfully mentor scientists in the Patient Centered Outcomes team, as well as Value Evidence and Outcomes. You may be called upon to participate on various leadership teams as required. You will also have opportunity to contribute to external efforts such as International Society of Quality of Life Research (ISOQOL), International Society of Pharmacoeconomics & Outcomes Research (ISPOR), CPATH, FDA initiatives, National Institute of Health (NIH) initiatives etc. If selected, your KEY RESPONSIBILITIES will include: Developing global PRO/COA endpoint strategic plans in collaboration with early and late stage clinical development teams, health outcomes and integrated evidence teams to assure alignment with product franchise goals Implementing PRO)/ COA strategies for assets in development, assuring alignment with clinical, health outcomes and commercial strategies and overall clinical development plan Coordinating and leading the development, validation, analysis, interpretation and utilization of PRO/COAs in the context of clinical trials and/or observational studies Ensuring PROs are implemented appropriately in clinical trials, which include writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials Collaborating with clinical and statistical teams to ensure that COAs are appropriately analyzed and described in statistical analysis plans, study reports and publications Preparing relevant sections of documentation and communication and questions for regulatory agency meetings, supporting and/or participating in meetings at regulatory agencies, and providing robust evidence in support of submission activities Preparing abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy Collaborating externally to ensure that client has expertise in newly evolving COA methodologies and is recognized as a leader in COA development and implementation With PRO team, developing and providing training on COA-related topics to other departments, as needed

Keywords: Robsco Search, Philadelphia , Director VEO PCO, Executive , Philadelphia, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Strategic Account Manager, Healthcare - Spectrum Enterprise
Description: At a glance:Are you a motivated client-focused sales expert familiar with the needs of healthcare organizations Can you commit to a consultative sales position growing existing accounts by guiding them (more...)
Company: Spectrum
Location: Whitestone
Posted on: 10/17/2019

Director, Change Enablement & Training
Description: GENERAL SUMMARY: br br The Director, Change Enablement and Training leads a team serving as agents of change and a catalyst for the adoption of new student experiences, technologies, and strategies. (more...)
Company: Laureate Education Inc.
Location: Columbia
Posted on: 10/17/2019

Spectrum Community Major Accounts Manager
Description: The Spectrum Major Accounts Manager is under the supervision of the Sr. Director of MDU Sales, this position is responsible for the negotiation and documentation of Rights-of-Entry ROE and Bulk agreements (more...)
Company: Spectrum
Location: Albertson
Posted on: 10/17/2019


Continuous Improvement Manager
Description: Company is a global multi-billion dollar capital equipment manufacturer with a strong
Company: Job Juncture
Location: Baltimore
Posted on: 10/17/2019

Program Manager
Description: Responsible for the performance of relatively small technical projects or a definable portion of a larger technical program in accordance with contract requirements and company policies, procedures and (more...)
Company: KeyW
Location: Severn
Posted on: 10/17/2019

Department Manager
Description: Description: McDonald's Works for Me. br I m going places. I want a satisfying career with good benefits and great opportunities for advancement. I have a lot to offer and I want to grow. br The Job (more...)
Company: McDonald's
Location: Laurel
Posted on: 10/17/2019

92Y Unit Supply Specialist - Warehouse Manager
Description: AGE REQUIREMENTS: Must be between the ages of 17 and 35 br br As a Unit Supply Specialist for the Army National Guard, you will ensure that your Unit and fellow Soldiers are well supplied and equipped (more...)
Company: Army National Guard
Location: Reisterstown
Posted on: 10/17/2019

Manager, Sales Strategic Accounts - Healthcare - Spectrum Enterprise
Description: At a glance:Are you a client-focused and growth-motivated business-to-business B2B sales expert talented in managing a high-performing team Can you commit to a leadership sales role educating clients (more...)
Company: Spectrum
Location: New York
Posted on: 10/17/2019

Program Understanding and Learning Suite (PULSE) Manager
Description: General Summary/Purpose The Johns Hopkins Bloomberg School of Public Health Center for Communication Programs CCP is a world-renowned organization that uses social and behavior change communication, (more...)
Company: Johns Hopkins University Center for Communication
Location: Baltimore
Posted on: 10/17/2019

Nurse Manager: Cardiac OR
Description: Nurse Manager: Cardiac OR Requisition : 179532 br Location: Johns Hopkins Hospital Nursing, Baltimore, MD 21201 br Category: Nursing Management/Leadership br Work Shift: Day Shift br Work Week: (more...)
Company: Johns Hopkins Hospital Nursing
Location: Baltimore
Posted on: 10/17/2019

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Philadelphia RSS job feeds