Senior Director/Director, Head of Clinical and Regulatory Informatics

Location
San Francisco, CA, United States
Posted
May 30, 2021
Ref
5115476002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Nurix is seeking an experienced candidate to provide the guidance, strategy, implementation and management of Nurix Clinical Development and Regulatory Information Infrastructure, and support the company's growing clinical pipeline.

The Head of Clinical and Regulatory Informatics will evaluate, propose timely, strategic implementation roadmaps and budgets, and implement a Nurix long-term, high-performance, and cost-effective Clinical Informatics Strategy to support all Nurix Management, Clinical, and Regulatory teams. He/she will be responsible for executing this strategy, ensuring the utmost availability and reliability of all clinical information management systems, data, and processes, and lead a cross-functional Clinical Informatics team ready to support all Nurix Clinical Development goals.

The successful candidate will have a passion for solving technical challenges and build collaborative relationships with members of all Nurix Clinical Teams; Program Management, Clinical Operations, Pharmacovigilance, Quality Assurance & Regulatory Affairs, Clinical Research, Translational Science, Biometrics & Biostatistics, CMC & Drug Supply Logistics, including with external CROs and collaborators.

The COVID-19 pandemic resiliency has demonstrated that teleworking has become a huge part of many companies' futures. Nurix's strategy is to favor remote work for this position whenever possible, with occasional meetings or retreats scheduled for the teams to interact in person as necessary.

Job Responsibilities:
  • Lead the strategic development and management of Nurix Clinical Information and Data Infrastructure to support all Nurix short and long-term Clinical Development and Regulatory goals.
  • Evaluate, propose, implement, and manage all Nurix Clinical and Regulatory Information Systems as needed to support Nurix Clinical Programs and Processes.
  • Ensure the utmost data quality, compliance, confidentiality, security, and availability of all Nurix Clinical Data and Systems, and facilitate all Regulatory Information exchanges between all clinical development stakeholders, Partners, CROs, and consultants.
  • Work with the Quality Assurance and Compliance Team to develop strong IT Access Control and Validation SOPs and support any “open” and “closed” systems in Nurix Clinical and Regulatory Information Infrastructure. Develop key relationships with all Nurix best-in-class clinical software vendors and CROs IT Teams, to coordinate validation activities of clinical data or regulatory information exchanges.
  • Provide first line of technical support for all clinical, regulatory systems and processes, clinical data collection, integration, reporting, exchange, and implement efficient and reliable validation, due diligence, audit, and regulatory submission processes.
  • Facilitate and ensure the harmonization, normalization, and efficient exchanges of all Nurix Clinical, Translational Research, Pharmacovigilance, Biostatistics and Biometrics data, using industry data standards and formats supported by regulatory agencies.

Required Qualifications:
  • Bachelor's degree (BS/BA), with extensive clinical systems and data management experience supporting clinical trials and approval of pharmaceutical products.
  • Demonstrated experience (15/10yr+) in a leadership management role building and providing guidance to cross-functional teams to support Clinical Programs Development and Regulatory efforts.
  • Extensive knowledge of many information systems and vendors used to support Clinical Programs Development, Clinical Operations, Clinical Data Management, Regulatory Publishing, Quality Assurance & Compliance Management.
  • Collaborative spirit and ability to work with project teams, external investigators, and contract research organizations.
  • Highly motivated, innovative, and strong team player, with a solutions and results-oriented focus.
  • Excellent organizational skills and project management required.
  • Excellent verbal and written communication skills

Company:

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.