General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for Clinical Operations and Development compliance for Sage therapeutics. This role will partner with Quality Assurance and Clinical Operations, providing expertise and guidance regarding regulatory requirements, GCP guidelines, and Sage Standard Operating Procedures (SOPs) for the conduct of clinical studies. The position will identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address clinical quality and compliance risks. The Director, Clinical Compliance serves as an important conduit to the broader organization to ensure a culture of quality and compliance.
Roles and Responsibilities
- Partner and develop strong relationships with Clinical Operations and Development and Quality Assurance personnel across functions and teams, providing coaching and compliance guidance as needed.
- Act as the Clinical Compliance lead of clinical study teams for relevant Therapeutic Areas.
- Provide leadership and direction to Sage Clinical Operations and Development stakeholders on GCP related activities/issues and act as GCP expert/consultant for Clinical Operations colleagues.
- Lead / manage inspection readiness activities in Clinical Operations and Development.
- Perform cross-functionally to understand organizational needs, complete gap analyses, enable process development, and conceptualize as well as implement best practice opportunities.
- Create and gain approval for best practice documents, standard operating procedures (SOP’s), and templates consistent with ICH/GCP principles.
- Provide ICH/GCP guidance and Clinical Compliance knowledge to all stages of clinical trials (document creation, plan development, vendor oversight, trial initiation/maintenance/closure, and CAPA management).
- Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify: priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities.
- Identify and escalate significant quality and compliance issues to the Head of Clinical Operations and Development and leadership in Quality Assurance.
- Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
- Lead SOP gap analyses, SOP writing, and SOP reviews.
- Establish relationship with CRO Quality Team member for the ongoing review of quality and compliance issues.
- Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
- Identify and anticipate quality trends in clinical operations and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
- Maintain high level of expertise in international GCP regulations and internal Policies and Procedure that may impact drug development.
- Provide support and guidance during and following Clinical internal audits and external regulatory inspections (as required).
- Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- BS required, Master’s or above preferred.
- Minimum of 10-12 years of pharmaceutical or biotechnology industry experience, with at least 5 years in a quality assurance/regulatory compliance position within Clinical Operations. Clinical Operations experience is essential.
- Thorough knowledge and understanding of drug development and the clinical trial process.
- In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required. Working knowledge of GLP requirements is a plus.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.