Senior Manager, R&D Integration Program jobs in United States
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Vantive · 8 hours ago

Senior Manager, R&D Integration Program

Vantive is a vital organ therapy company focused on innovations in kidney care, aiming to enhance the dialysis experience through digital solutions. The Senior R&D Integration Program Manager will lead R&D project management for complex drug products and medical devices, facilitating cross-functional collaboration and technical decision-making to support the company's mission of extending lives.

Health CareMedicalTherapeuticsWellness

Responsibilities

Lead research and development (R&D) project management work for large, multi-site cross-functional programs and facilitate technical decision making for drug products, medical devices, and other regulated healthcare products
Contributes to the creation and implementation of the Drug Product and Sciences Integration Office by assessing current status and recommending new and best practices for the organization
Develop complex program plans and own Owner of R&D program schedule creation, tracking, and execution. Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans
Drives interactions and resolution of technical issues with other R&D functions and cross-functional interfaces for complex projects
Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables
Accountable for project execution and proactive risk management. Effectively tracks project status, risks, budget, and external spend
Capable of complex scenario planning to arrive at the optimal solution for the program with regards to schedule, budget, scope and risk management
Effectively tracks project status, risks, budget and external spend
Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis
Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project
Establish project communication channels and archives. e.g., Teams group, Status meetings, Escalation matrix, etc
Facilitate/organize DPS R&D project design reviews and similar decision meetings
Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.)
Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities

Qualification

R&D ExperienceProject ManagementTechnical LeadershipRegulatory ComplianceQuality ControlSupplier ManagementInterpersonal SkillsCommunication SkillsProblem Solving

Required

Bachelors degree in Engineering, Science or equivalent field
15+ years of R&D experience; 10+ years project management experience
Experience in pharmaceuticals or medical device industry required
Deep experience in project management principles and methodologies; multiple cycles of successful product development experiences
Strong interpersonal and communication skills in written and verbal form
Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.)
Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope
Ability to decompose complex problems into actionable plans and track them to closure
Understanding of design requirements for development, validation, and verification of medical products

Benefits

Medical, dental and vision coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Aon Pooled Employer Plan (“Aon PEP”)
Vantive’s 401(k) retirement savings plan
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
The Employee Discount Program
The Employee Assistance Program (EAP)
Childcare benefits

Company

Vantive

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Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions.