Director, R&D Compliance & Standards (GCP Quality)

Company: Horizon Therapeutics
Location: Schaumburg
Posted on: May 28, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us. The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. Position Summary The Director of RDCS is responsible for delivering all aspects of R&D Compliance & Standards. This is focused on compliance and standards across R&D to be compliant with Horizon process and regulatory requirements. Responsibilities Provide leadership, mentorship and motivation to a complex, distributed, group delivering upon critical business needs. Effectively prioritize and plan work deliverables across the groups, managing competing needs and uncertainties. Align departmental work with larger R&D goals. Communicate effectively internally across Horizon the roles and deliverables of the RDCS to ensure delivery and collaboration is maximized. Identify and resolve areas of cross over, or handoff, with other Horizon functions that impact RDCS & Core Function delivery. Continually assess operating model for opportunities for innovation and simplification, expert knowledge of external regulatory requirements to determine changes in practices and standards within Horizon. Implement an audit plan per study that supports clinical team in delivery of well controlled trials. Lead site and vendor audit planning, collaborate, communicate and delivery with clinical teams. Escalate and resolve issues in a manner consistent with Horizon SOPs. Inspection readiness and inspection conduct leadership through the team. Train, lead, collaborate and plan across R&D for successful inspection preparation and conduct. Develop, communicate and conduct inspection readiness plan per development asset, prioritized to risk and business need. Develop risk assessment tool to support teams focused on inspection preparation using study performance metrics to identify and prioritize site risk and inspection likelihood. Deliver through the R&D Compliance team the organizational compliance needs for R&D compliance metrics and trending, presented through compliance dashboards study risk assessment and CAPA implementation SOP renewal and mapping Deviation identification and tracking per Horizon QMS needs Provide compliance feedback into study protocols, ICFs, IBs and CSRs PSMF review and approval Support teams with unblinding needs and process Ensure compliance with Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), standards and all applicable regulations and guidelines. Qualifications and Skills Required Bachelors of Science required. Advanced degree (PhD or PharmD) preferred. Minimum of (12) years of clinical research experience specialty areas clinical research within biotechnology, biopharmaceutical, and/or pharmaceutical companies within a similar role, including monitoring and management of clinical studies with appropriate knowledge of regulations. Ability to travel independently up to 20% over the course of a year Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Demonstrated effective personnel and project leadership experience. Domestic and international clinical trial experience. Excellent interpersonal skills. Excellent knowledge of GCP compliance issues. Proficient in Microsoft Office. Professional, proactive demeanor. Strong interpersonal skills. Excellent written and verbal communication skills. LI-REMOTE Our Values Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference. Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures. Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients. These three values come to life through our five Leadership Expectations that apply to all Horizon employees Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role Compensation and Benefits Summary: The salary range for this role is $193,500.00-$236,500.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications. In addition to the salary, this position is eligible for the benefits listed here and for the following plans: Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate Bonus At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better. Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Schaumburg , Director, R&D Compliance & Standards (GCP Quality), Executive , Schaumburg, Illinois