Please Note That This Is A 12 Months Contract Position.

Must Haves:

Pm Experience
Related Industry With Medical Device, Diagnostics, Clinical Test Lab Or Pharma
New Product Development

Job Description:

In The Companion Diagnostics Business (Cdx), Our Team Partners Very Closely With Leading Pharmaceutical Companies To Develop, Manufacture And Commercialize Highly Regulated Medical Devices Which Are Critical For Physicians To Help Select Therapies For Their Patients.

Become A Part Of A Growing And Dedicated Team That Does Truly Inspiring Work In The Field Of Precision Medicine. Our Employees Are Passionate About Their Contributions Because There Is A Very Direct Connection To Helping Patients With Cancer.

Reporting To The Director Of Program Management You Will Lead A Cross-Functional Project Team In A Matrix Organization Located In The Carpinteria, California Office; The Center Of Excellence For The Companion Diagnostics Division.

In This Exciting Role You Will Have Responsibility For Ensuring The Client Is: 1) Leading The Way In Companion Diagnostic Product Development And 2) Will Support Projects Focused On The Transition Of Client’S Companion Diagnostic Products From In Vitro Diagnostic Directive To In Vitro Diagnostic Regulation (Ivdr – New European Regulation) Compliance.

You Will Be Externally Facing To Pharmaceutical Industry Partners And Internally Facing To The Cdx Core Project Team. The Successful Person For This Job Will Work Closely With Their Global Cross-Functional Project Teams And External Partners To Ensure That The Project Objectives Are Accomplished Within Prescribed Time Frame And Budget.

Qualifications:

Job Responsibilities:

Experience Leading Global, Multi-Site, Cross-Functional Project Teams, And Serving As A Direct Contact Between Pharma Project Managers And Cdx/Dgg Project Stakeholders With Oversight From Project Management Director Or Senior Program Manager
Driving And Delivering Expected Results According To Agreed Project Scope, Cost, Quality And Timeline Milestones
Creating And Managing Resource Forecast Plans, And Working Directly With Line Managers To Communicate And Agree To Project Staffing Requirements
Tracking Estimated Project Revenues, Costs, Expenses And Profits Against Defined Metrics; Proactively Communicating Deviations To Relevant Stakeholders, Internal And External
Obtaining Partner Approval For Completed Milestones
Analyzing, Planning And Tracking Project Phases And Activities, And Communicating The Timelines/Milestones/Goals On A Regular Basis To Cdx/Dgg Management, The Project Team And Other Stakeholders
Coordinate With Third Party Vendors As Required To Complete The Project Activities
Manage The Receipt And Transfer Of Assay Production Requests To The Appropriate Supporting Functions In Order For Them To Deliver Assays For Their Intended Use Such As In Clinical Trials Or Internal Development Activities
Effectively Identify And Communicate Risks To Stakeholders In A Timely And Clear Fashion
Understanding Of The Proper Application Of Risk Management Techniques To Ensure Business Priorities And Quality Standards Are Met
Re-Evaluating Goals Throughout The Project, Together With The Project'S Stakeholders, And Making Necessary Adjustments To Project Plans And Budgets, Including Scope Change Management
Participating In Preparation And Alignment Of Decision Process In Joint Project Governance Bodies; Including But Not Limited To Joint Project Teams (Jpts) And Joint Steering Committees (Jscs)
Establishing And Maintaining Project Lifecycle Documentation
Accountability And Urgency For The Delivery/Completion Of Projects On Time And Cost
Ability To Work Collaboratively With External Customers To Ensure That Company And Partner Interests Are Addressed In A Balanced Fashion
Ability To Establish Trust And Work With Integrity While Motivating Others To Achieve The Goals Of The Project
Developing Leadership Skills And Desire To Succeed With A Moderate Level Of Guidance
Successfully Multi-Task Amongst Several Competing Initiatives
Excellent Presentation Skills
Creative Problem-Solving Skills And Decision-Making Abilities That Adapt To Change And Promote Teamwork Across Geographies And Cultures
Ability To Influence Internal And External Stakeholders At All Levels In A Matrixed Team Environment
Experience With Constructive Decision Making, Resolution Of Conflict, And The Building Of Effective Top-Down And Bottom-Up Business Relationships
Active Ownership Of Problems Of Diverse Technical And Business Scope Where The Analysis Requires In-Depth Evaluation And Research Of Competing Options

Required Qualifications

Education:
Bachelor’S Degree In Science Or Related Field
Project Management Experience With An Understanding Of The Biological Or Life Sciences
Pmp Certification A Plus

Experience:
Minimum Of 2-4 Years Of Project Management Experience Managing Complex Product Development Projects With A Bachelor’S Degree

1-2+ Years Of Project Management Experience Managing Complex Product Development Projects With An Advanced Degree

And

1-2+ Years In A Regulated Industry

(Such As Medical Devices, Diagnostics, Pharmaceutical Or Biotech Industry

Must Have A Good Understanding Of Project Management Principles, Concepts, Practices And Standards
Experience With Managing Project Scope And Maintain Team Focus On Quality While Driving Results According To Project Timelines And Goals
Must Have Exceptional Interpersonal And Communication Skills With The Ability To Effectively Communicate At All Levels In The Organization And Across Locations
Excellent Time Management Skills And Ability To Work Independently With Moderate Guidance
Excellent Presentation Skills
Strong Analytical Skills With A Proven Ability To Balance And Prioritize Responsibilities In Accordance With Business And Team Needs
Ability To Influence At All Levels Within The Organization.
Creative Problem-Solving Skills And Decision-Making Abilities That Adapt To Change
Experience With Maintaining Project Financials And Budgeting Including Cost/Spend Analysis And Revenue Forecasting
Good Working Knowledge And Recent Experience With Use Of Microsoft Office Applications (Word, Excel, Powerpoint, Outlook), Sharepoint And Remote Meeting Tools Such As Webex, Teams, Etc
Experience With Project And Portfolio Management System Clarizen A Plus

Preferred Qualifications

Eu Mdr Experience
Ivdr (In Vitro Diagnostic Regulation -- New Regulation Coming From The Eu)
Ivds (In Vitro Diagnostics) Or Cdx (Companion Diagnostics)
Experience With Design Control, Assay Development, Ivds, Ihc, And/Or European Regulations (Such As Ivdr Or Eu Mdr)

Applicants Must Provide Their Phone Number. Reference Job Number A698.