- Collaborate with R&D Scientists, IT and Quality to provision and support enabling systems for Sana's R&D group
- Hands on role for systems throughout their lifecycle
- Provide system ownership for a set of systems, managing roadmap, technical change management and regression testing of releases
- Serve as a key team member for defining and implementing the data strategy, involving the aggregation and analysis of large data sets to identify key trends and insights that advance scientific understanding
- Hold overall accountability for meeting the project aims for projects within the scope of the role, including delivery of the agreed value within the stated timeline and budget
- Serves as a subject matter expert (SME) for assigned R&D systems and processes during regulatory inspections and internal audits pertaining to R&D activities
- Partner with internal IT teams to deliver IT infrastructure, compliance and other projects, in support of R&D operations
- Manage assigned external vendors / service providers, negotiating contracts, managing the finances and assuring delivery of the agreed value
- Identify opportunities to avoid unnecessary spend
What we're looking for - Experience in IT supporting multiple R&D functions and data domains (e.g., preclinical, genomic, comp biology, clinical, safety, regulatory, real-world data, etc.). Considered to have in depth knowledge of drug discovery and development
- Embraces hands on work for enabling R&D functions through technology
- Veeva, Benchling and AWS Cloud experience required, elluminate is a plus
- PhD with 4-6+ years' experience or MS with 6-10 years' experience in the pharmaceutical / biotechnology industry or healthcare sector, with joint experience / degree in Computer Science, Medical Informatics or Bioinformatics
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry
- Good understanding of regulations and GCP requirements for drug development.
- Advanced knowledge of systems enabling R&D, including exporatory research in the lab, clinical data capture, clinical data management, clinical operations and biostatatistical analysis.
- Advanced experience working on Phase I-IV clinical studies; capable of leading technology related activities to support regulatory submissions and inspections
- Good understanding of CDISC standards including SDTM & CDASH, as well as medical coding dictionaries (ICD, MedDRA, WHODrug, SNOMED CT)
- Robust understanding of the data analytics value chain from data to decision
- Proficiency in Microsoft Office, including process mapping/project management tools such as Jira, Smartsheet's, Visio and Project
- Understands cloud-based/SaaS systems
- Ability to communicate effectively and professionally, both orally and in writing, while also articulating and translating technical language to non-technical customers
What will separate you from the crowd. - Experience with modern data technologies/stack such as cloud services (AWS & Azure), Databases (Redshift, Snowflake), RPA and other automation enablers
- Experience in machine learning and AI powered products.
- Experience with core IT domains like infrastructure, operations, and cybersecurity
- Experience with Agile methodology
What you should know - Office location is Cambridge, MA, with some required travel
- The base pay range for this position at commencement of employment is expected to be between $200,000 and $230,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients - Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
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Director, R&D IT - Cambridge, United States - Sana Biotechnology
Description
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As the Director R&D IT you will report to the Head of R&D IT, to collaborate with the IT and business teams in the provision of technology enablers for Sana's R&D group, supporting various R&D systems. This is a very hands on role due to the small team size. We are looking for an experienced R&D Director, with extensive knowledge of technology and processes that can enable R&D, with an thorough understanding of GCP, 21 CFR Part 11, Annex 11 as well as systems for R&D exploratory research, clinical data capture, data management, storage and analysis.
What you'll do
