Associate Director/Director, IT Regulated Systems - Scorpion Therapeutics
Boston, MA
About the Job
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.
Job Summary
Scorpion Therapeutics is on the lookout for a seasoned senior IT leader with a knack for regulated GxP systems. This role is a golden opportunity to work cross-functionally with teams like Quality, Clinical Operations, Regulatory, and more. You will take on a leadership role within IT as the business partner for the development functions. You will aid in road mapping their regulated systems needs along with associated budgets. You work on implementing agreed upon systems and managing their ongoing lifecycles.
Responsibilities
- Be the primary business partner to key development functions. In doing so aid in developing long-term roadmaps and budgets. Provide guidance on appropriate systems that best suite Scorpion's strategic direction.
- Manage internal/external resources where needed to aide in driving Scorpion's to drive successful outcomes.
- Where necessary take on the project manager role during system implementations.
- Create and maintain necessary Standard operating procedures, policies and work instructions as required.
- Take on the lead role in dealing with necessary vendors and associated contracts.
- Where necessary provide system user and configuration management.
Requirements
- A minimum of 5 years working within the life sciences industry with direct experience with FDA & EU regulated systems.
- A minimum of 10 years working within IT and related technical experience.
- Solid understanding of 21 CFR Part 11 rules and how it pertains to implemented systems and SOPs.
- Proven ability to partner with business leaders to provide positive outcomes for the business.
- Experience with vendor contracts and budgets.
- Solid understanding of SaaS systems vs traditional on-premise (self-hosted) systems.
- Experience in system implementations, change controls and overall lifecycle management.
- Experienced in SOP drafting and lifecycle management.
- Proficient in communicating cross-functionally and conflict resolution.
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.