Director, Cross TA Clinical Risk Management

Role Overview

• Oversee the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness;
• Manage a team of CRM representatives that will provide consistent quality oversight to clinical trials in the Cross TA portfolio;
• Provide and lead strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies.
• Approve CQP (Clinical Quality Plans) risk monitoring information in the quality risk repository to facilitate regular progress reviews;
• Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews;
• Ensure a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations;
• Communicate and facilitate risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned);
• Develop and ensure a consistent interpretation of issues that require quality investigations;
• Provide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management;
• In collaboration with partners in RDQ, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self
• Identified, Inspection, Audit);
• Independently lead key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams;
• Provide remote support for investigational site inspections including post inspection support;
• Provide independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy;
• Participate in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead);
• Work with limited supervision, independently making quality decisions for compounds and studies;

Requirements

• A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
• Demonstrates experience or recognizes potential for people leadership in formal or informal setting as needed is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Immunology Drug Development experience is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Requires up to 10% travel, primarily domestic with some international travel.

Tech Stack

• Google Cloud Platform
• Tableau

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year