What are the responsibilities and job description for the Associate Director, Clinical IT position at Olema Oncology?
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role >
Associate Director, Clinical IT
As the Associate Director, Clinical IT reporting to the Director Clinical IT you will implement, manage, and improve GxP systems per regulatory requirements and guidelines to support Olema's Phase 3 clinical programs. You will lead and oversee all aspects of our clinical systems, ensuring they adhere to the highest standards of Good Clinical Practice (GxP) and regulatory compliance. In this role you will be a technical subject matter expert (SME) for clinical systems, providing guidance and support to internal stakeholders. Additionally, you will collaborate with other GxP functional departments (QA, Regulatory, Clinical Operations, Biostatistics) to develop and implement phase appropriate clinical system processes at Olema.
This role is based out of our San Francisco, CA or Cambridge, MA office and will require up to 5% travel.
Your work will primarily encompass :
- Implementation and management of GxP applications and system enhancements, ensuring they align with business needs, regulatory requirements, and user workflows.
- Oversee the entire GxP regulated systems lifecycle, including selection, implementation, validation, migration, periodic reviews, maintenance, and retirement.
- Champion and manage change control activities for clinical systems, mitigating risks and ensuring smooth transitions.
- Serve as a technical SME for GxP systems, providing expert advice and guidance to internal teams.
- Lead and manage the computer software validation (CSV) and computer software assurance (CSA) processes for clinical systems.
- Stay abreast of evolving GxP regulations and industry best practices, proactively implementing necessary updates to clinical systems.
- Collaborate with Clinical Development organizations, and other departments to ensure seamless integration and optimal utilization of clinical systems.
- Develop and maintain comprehensive documentation for clinical systems, including policies, procedures, and job aids.
- Maintain and manage audit documentation (external and internal) at Olema ensuring completeness and readiness.
- Manage Olema's vendor partnership for managed services support and release management.
- Creating and deliver Clinical Systems key performance and quality metrics to Leadership and Executive Management.
- Promoting a culture of quality and operational excellence at Olema.
Ideal Candidate Profile >
Experienced Associate Director of Clinical Systems
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 :
Experience :
Attributes :
The base pay range for this position is expected to be $189,000-$195,000 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.
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Important Information >
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note : Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note / Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
Salary : $189,000 - $195,000
