|Reference # : ||17-01493
||Title : ||Excellent job opportunity of Project Manager III, 5929808|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||03/01/2017 / 02/28/2018
| Description |
|Job Title: Project Manager III|
Location: Cambridge, MA
Duration: 12 months
Client: A Big Pharmaceutical Client
Overview of PRO/COA Scientist role
The Clinical Outcome Assessment (COA) / Patient-Reported Outcome (PRO) team at Client is part of the Global Health Economics and Outcomes Research (HEOR) function. The remit of the COA/PRO team is to incorporate the patients’ perspective into clinical research through the utilisation of COAs and other methods. The primary focus of the COA/PRO team is on developing, assessing, using, interpreting and diseeminating PROs, Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs) to derive treatment benefit during the clinical development of new molecules (Phase 2-4).
At Client, each molecule in development is assigned a HEOR subteam, comprising a generalist (HEOR Business Partner) and representatives from relevant expert functions such as epidemiology, economic modeling, real world insights, and COA/PRO. This HEOR subteam works with cross-functional business partners, including Research and Development, Medical Affairs, Market Access, Statistics, and Commercial to set and deliver strategic HEOR (including COA) plans.
As a consequence of a recent restructure at Client the number of molecules to be supported by the COA/PRO team has significantly increased. New molecules include those within the Rare Disease and Multiple Sclerosis (MS) portfolios that are part of the Client Genzyme Business Unit. Client Genzyme are based in Cambridge, USA. In order to meet the needs of the business, the PRO team is looking to expand its team to include an experienced PRO/COA Scientist to lead the function in these areas.
COA development and use
COA summary and dissemination
- Provide expert advice on COA measurement needs to HEOR Business Partners and cross-functional molecule teams to ensure well designed HEOR plans are developed and implemented. Ensure these reflect the need for COAs from multiple stakeheolders, including (where relevant), regulators, payers, healthcare professionals and patients
- Develop COA endpoints as appropriate for the clinical development programs. Includes managing research required to support the selection, development and validation of COA measures, including qualitative research.
- Manage vendors as needed
- Ensure proper input into HEOR plans, and effective implementation related to COAs throughout execution, including writing relevant portions of the clinical trial protocols, training investigative site personnel on COA principles and appropriate administration of COAs in the clinical trials. Develop statistical analysis plans for COAs, and with statistics, analyze and interpret the COA results from the clinical trial.
COA licencing and translation
- Prepare relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in said meetings at regulatory agencies, and provide robust evidence in support of submission activities.
- Prepare abstracts and manuscripts presenting COA results from clinical and COA development and validation studies, aligned with publication strategy
- Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR Working Groups.
- Participate in creating and delivering education on PROs for internal business partners
- Assist the PRO Project Coordinator in securing licences and commissioning translations/adaptations for COA instruments in a timely manner
Fluent in English (written and spoken)
- Must be willing and able to travel globally
- Understanding of regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, other local agencies) environment, including emerging joint regulatory/HTA review process
- Clear knowledge of epidemiology and real-word evidence methods
- Knowledge of the drug development process
- Strong analytical and synthesis skills of qualitative and quantitative data
- Excellent understanding of research principles and recent developments in COA
- Scientific rigor, autonomy and sense of initiative
- Good interpersonal and communication skills, both written and oral; ability to understand and communicate with representatives from the range of disciplines
- Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment
- Ability to work effectively either in small teams or independently
- Ability to interact and manage external and internal networks
Relevant advanced academic degree (e.g. doctorate or masters in health economics, clinical psychology, public health, epidemiology, psychometrics)
Training in COA methods
Interested candidates can share their updated resume at email@example.com or reach out to me at 973-295-4583
- At least 5 years of HEOR pharmaceutical industry, CRO or academic experience
- At least 3 years of relevant experience in COA
- Proven track record in some HEOR disciplines incl. data analyses, scientific publication & input to clinical trials