Senior Director, Clinical Compliance / Inspection Readiness
Apply NowCompany: Merus
Location: Cambridge, MA 02139
Description:
Senior Director, Clinical Compliance / Inspection Readiness
Application Deadline: 28 May 2025
Department: Clinical Operations
Employment Type: Full Time
Location: Cambridge, MA
Description
Company Overview
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients' lives. We have bold aspirations, because the need is great and the patients are waiting.
Join our mission to close in on cancer. We are seeking a Senior Director for the Clinical Operations team with a focus primarily on Clinical Compliance and Inspection Readiness. This role involves leading the clinical operations teams with a focus on compliance and overseeing the management of all compliance activities on our programs to ensure inspection-ready at all times.
Your role:
The Senior Director, Clinical Compliance/Inspection Readiness is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues which will include:
Your profile:
The ideal candidate will have extensive experience with compliance processes, regulations, oversight documents, training, and Quality systems and will be responsible for oversight of compliance in all programs and of our eTMFs.
Our offer:
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you'll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you'll have the chance to join us as we close in on cancer - everything you do matters at Merus.
Application Deadline: 28 May 2025
Department: Clinical Operations
Employment Type: Full Time
Location: Cambridge, MA
Description
Company Overview
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients' lives. We have bold aspirations, because the need is great and the patients are waiting.
Join our mission to close in on cancer. We are seeking a Senior Director for the Clinical Operations team with a focus primarily on Clinical Compliance and Inspection Readiness. This role involves leading the clinical operations teams with a focus on compliance and overseeing the management of all compliance activities on our programs to ensure inspection-ready at all times.
Your role:
The Senior Director, Clinical Compliance/Inspection Readiness is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues which will include:
- Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization.
- Lead the development and implementation of processes and tools to support teams and functions in being inspection-ready.
- Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring.
- Prepare and execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding.
- Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities.
- Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
- Generate, analyze, and communicate oversight, compliance, and inspection readiness metrics.
- Drive continuous improvement into inspection readiness and inspection conduct support.
- Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms, and templates in compliance with global regulatory standards.
- Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization.
- Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance.
- Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
- Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
- Generate, report, and respond accordingly to compliance/inspection readinessKPIs.
- Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.
Your profile:
The ideal candidate will have extensive experience with compliance processes, regulations, oversight documents, training, and Quality systems and will be responsible for oversight of compliance in all programs and of our eTMFs.
- Bachelor's degree or international equivalent in information management, library science, clinical science, or a related field.
- 12-15 years of experience in global clinical trials and operations.
- Experience with compliance processes and implementation, preparation, and conduct of audits and audit follow-up including CAPA creation and completion, previous inspection preparation experience, inspection execution, computerized clinical trial records management technologies, particularly Veeva systems. Experience in storyboard creation and driving and training teams towards implementation of storyboard creation and filing.
- 5-8 years of personnel management experience, with a proven track record of mentoring and developing teams.
- Strong organizational, writing, and communication skills.
- Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.
Our offer:
We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you'll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you'll have the chance to join us as we close in on cancer - everything you do matters at Merus.