Clinical Outcomes Director jobs in New Jersey

Hi,

My name is Gaurav, and I am a recruiter with Net2Source Inc. Our direct client is looking to hire a Associate Principal Scientist in their growing team.

Please find below the job description.

Title : Associate Principal Scientist

Location: West Point, PA or Rahway, NJ

Hybrid (3 days onsite between Monday-THRU)

Duration: 24 Months (Extendable)

Responsibilities:

Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas.

Primary activities include but are not limited to:

• Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals.

• Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies.

• Provide guidance on implementing COA/PRO instruments into studies by following Merck standard processes.

• Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.

• Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies.

• Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies.

• Conduct literature searches to support COA/PRO endpoint strategies.

• Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)

• Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed

If the below expertise are not listed clearly on the resumes, candidate will not be shortlisted.

Please focus on the experience with Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs).

Types of COAs include:

• Patient-reported outcome (PRO) measures.

• Observer-reported outcome (ObsRO) measures.

• Clinician-reported outcome (ClinRO) measures.

• Performance outcome (PerfO) measures.

Day to Day:

Contractor will go under training for a month, including corporate training, specific training within the team, Onboarding training.

• This role will be backup support to a lead within the team.

• Attending team meetings.

• Review protocol, review analysis plans.

• This person will help the lead.

• Communicator/liaison

• Literature review, summarize paper.

• Prepare questionnaires that is put into our clinical trial.

Collect Patient Data:

• How are they feeling?

• Collect health status of patients.

• How to collect patient data?

• How do we make sure the correct questions are being asked to patients in the clinical trial?

• Patient reported data.

• Existing questionnaires to be included in the studies.

Qualifications:

Actual Title: Associate Principal Scientist

Department- Patient-Centered Endpoints & Strategy (PaCES)

Education:

• PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 3 years of relevant industry work experience in the COA field OR Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 5 years of relevant industry work experience in the COA field OR Bachelor's degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 10 years of relevant industry work experience in the COA.

Required Experience:

• Familiar with COA/PRO requirements for regulatory and reimbursement agencies

• Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies

• Ability to understand and respond to multiple internal and external customers.

• Strong project management and communication skills

• Experience with COA/PRO-related scientific presentations and publications.

Thanks

Gaurav Gupta

Sr. Pharma Recruiter

gaurav.gupta@net2source.com

201-331-8302