Randstad Senior Program Manager - CDx in Danvers, Massachusetts
Senior Program Manager - CDx
salary:$145,000 - $150,000 per year
date posted:Tuesday, November 17, 2020
industry:Professional, Scientific, and Technical Services
Senior Program Manager - CDx
*IMMEDIATE NEED for a Senior Project Manager in the Companion Diagnostic Space. This person will ensure that assigned Companion Diagnostic Programs are executed in alignment with agreed upon on time delivery metrics and within defined budget. *
location: Danvers, Massachusetts
job type: Permanent
salary: $145,000 - 150,000 per year
work hours: 9 to 5
The program manager supports the CDx project/program with specialized knowledge, expertise and problem-solving skills to achieve on-time-deliver (OTD) targets. The program manager also navigates and resolves business obstacles that may arise in the following:
Timeline and project plan
Risk management and mitigation
Budget and scope
Internal and external stakeholder communication
Support the Pharma Partnership BD team by working with line functions to prepare accurate program timelines, budgets, and Statements of Works (SOWs) for CDx programs. As needed, provides program management expertise and knowledge during the pre-sales process and alliance management support for advanced programs.
Using analytical thought, contributes to defining, monitoring, and reporting of KPIs and leading indicators to measure the success of the organization and identify risks/countermeasures.
Contributes their expertise to portfolio management by prioritizing and estimating resourcing needs for future work and identifying potential resource gaps of contracted and planned projects.
Prepare monthly and quarterly revenue forecasts with assumptions and defined risks and, at month end, report out actuals. Collaborate with Finance to standardize forecasting and reporting activities and improve process.
While this role will have no direct line management responsibilities, this is a leadership role with responsibilities to mentor and lead through influence within the program team and advocate for the program team.
Development of standard work and processes to support the business and advocate for continuous process improvement.
Advanced degree in the sciences (MS / PhD), such as biology, immunology or related field preferred.
Six plus years of proven experience working with pharmaceutical or biotech companies and understanding of drug development process.
Six plus years of proven experience in Project Management roles in a fast paced, changing Medical Device or Pharmaceutical environment in companion diagnostics is critical for this role.
Experience managing projects; using MS Project or similar project management software; and waterfall project management methods with an understanding of agile.
Experience working in a regulated environment and under design control. Understands the validation requirements for bringing a medical device through regulatory submission in NA or EU
Experience in preparing and executing statement of work documents
Experience in developing software as a part of a Medical Device and associated documentation.
Outstanding people management and collaboration skills in a global environment with an appreciation for cultural nuances.
Potential for future travel (20 - 25%) to work with key internal stakeholders and customer sites, travel is not currently taking place.
skills: MS-WORD, MS-Project, Biology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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