Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
This role is anything but the typical Compliance position. The Leader of Strategic Compliance within the Roivant R&D Quality Organization will have the unique opportunity to build a new model for biopharma product development. Traditional compliance models, especially in biopharma development, have many inefficiencies & do not innovatively identify & manage risk or seek to adopt new methodologies for continuous improvement. A trendsetting company, Roivant seeks inefficiencies across science & technology that we craft & mold into bold opportunities. Our compliance system needs to create value, embrace contrary measures, climb over risk, & sweat every detail. We seek to evolve the very nature of the traditional biopharma development compliance system, or we will die. We need one talented individual who will embrace the Roivant scrappy agility culture & drive us to create the compliance model that other companies only wish they could adopt. Our talented individual will be able to operate very strategically to develop high level plans as well as dive deep into the details & complete tactical operations. We are an all-hands-on-deck organization all the time. If you are this talented individual, we look forward to meeting you! This role will partner closely with the Head of Quality Systems ensuring that our efforts are synergistic in achieving our goals. The position will report to the Vice President of Quality & is a remote, work from home opportunity.
- Prospectively develop a novel compliance system for biopharma product development embracing total quality management, risk management, & continuous improvement as fundamental elements for our virtual company to shrink cost, minimize timelines, & improve overall quality of our deliverables & products
- Develop streamlined & simple platforms/tools/systems to use compliance strategically as a business tool throughout all GXP activities
- Develop compliance metrics eventually evolving into KPIs, both lagging & prospective
- Develop the culture & ethics models for product development & the needed compliance for our work
- Design the user & functional requirements for quality systems that collect & analyze information for Continuous Improvement, Risk Management, & Management Review
- Work closely with the Head of Quality Systems to build the infrastructure & systems for Product Development Compliance
- Manage the auditing program (internal & external), external surveillance program, & the data integrity/computer system validation program
- Responsible for the Quality Management System elements as related to the Strategic Compliance function
- Work closely with the Training Systems Lead to generate training related to our compliance model company-wide
- BA/BS degree with a scientific focus & 10+ years of experience in the biopharma industry or healthcare system
- Must possess knowledge of the value stream from biopharma product development through to regulatory agencies & to payors/patients, how to communicate this to management in support of how compliance improvements will benefit & build our business
- Understanding of regulatory compliance related to biopharma development
- Experience in fast paced, start-up environments particularly as they scale up
- A strategic thinker with excellent business judgment
- Highly motivated & willing to take on multiple responsibilities at once, highly performing at both the strategic & tactical level possessing strong interpersonal, organizational, & program management/project planning skills
- Highly innovative problem solver with a demonstrated ability to use any technology or platform to accomplish the goal
- Demonstrated leadership experience with Lean Leadership, Lean Agile, Design Thinking, Change Management, or Root Cause Analysis is highly desirable
- Excellent verbal & written communication skills; ability to deal with complex problems & present recommendations & findings in a clear, concise format