Senior Director, Clinical Compliance and Documentation

About the Role >>> Senior Director, Clinical Compliance Operations 

As the  Senior Director of Clinical Compliance and Documentation, reporting to the VP of Clinical Development Operations, you will act as the clinical compliance lead within clinical operations to ensure that Olema’s clinical trials, processes, and oversight are compliant with global regulatory standards (e.g. FDA, EMA, and other international regulatory authorities) and GCP. You will partner with the GCP Quality Assurance team to ensure safety and compliance in Olema’s clinical trials across different stages of development. You will also support the company’s business goals and objectives while building and maintaining a strong culture of compliance throughout the Clinical Department. 

This role is based out of our Cambridge or San Francisco office and will require 15% travel.  

Your work will primarily encompass: 

• Develop strategies for ensuring compliance in support of clinical study teams across different stages of development. 
• Leadership of risk and issue management process for CDO focusing on clinical study delivery.  
• Lead process improvements within the Clinical Department including providing trends and other relevant reporting to Process Owners and Clinical Department Leadership Team (CDLT) and help translate trends to enable smart risk taking and process improvement.  
• Lead the development of Clinical SOPs, work instructions, process flows, forms, and storyboards through partnership with Clinical Department Heads and QA. 
• Collaborate with QA in the response and completion of clinical audits and inspections.  
• Develop and manage Clinical and CRO Key Performance Indicators (KPIs) in order to provide oversight of our vendors and mitigate study operational risk.    
• Partner with QA to define strategy and methodology for Clinical risk/issue management; create annual risk management plan to ensure inspection readiness, review periodically the outcomes of risk management/ management monitoring; escalate to appropriate governance and adapt accordingly.  
• Oversight for completion of Root Cause Analysis of Issues and Clinical CAPAs and provide CDLT with reports of CAPA completion data (late, near due, due later). 
• Management and oversight of internal Clinical Systems (ex. eTMF) to ensure efficiency and standards of excellence.  
• Oversight of the Clinical Documentation and Trial Master File Team. 
• Onboarding of clinical department staff. 
• Protocol/Informed Consent/Manual Review and QC. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree is required, Master’s degree is preferred. 
• Extensive understanding of GCPs, FDA, EU and ICH regulatory standards/guidance documents. 

Experience: 

• 15+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8 years of specific experience working in clinical compliance and TMF management roles. 
• 5+ years of people management experience. 
• Late-stage clinical trial experience required. 
• Extensive process and storyboard writing experience. 
• Strong experience of ICH GCP guidelines, DIA TMF reference model, and FDA regulations.  
• Experience in inspection readiness and conducting FDA inspections. 
• Experience in building risk-based quality systems. 
• Experience in analyzing data, detecting and presenting trends/patterns related to auditing, monitoring and investigation findings. 
• Oncology experience is highly preferred. 

Attributes: 

• Proactive mindset. 
• Strong communication skills and the ability to effectively collaborate with key stakeholders. 
• Strong project management and time management skills. 
• Ability to mentor others. 
• Ability to execute on day-to-day responsibilities with minimal supervision. 

The base pay range for this position is expected to be $230,000- $245,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1