Director, Clinical Data Management

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.  

Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. 

You can view our latest corporate deck and other presentations here.

About the Role >>> Director of Clinical Data Management 

As the Director of Clinical Data Management reporting to the Sr. Director, Clinical Data Management, you will be responsible for all data processes related to assigned studies, overseeing data collection workflows across all data sources, ensuring the quality and integrity of all clinical data including CRF and edit check specifications, Data Management Plans, data systems validation and UAT, listings generation, as well as ensuring review of clinical data for completeness, accuracy, and compliance.  

This role is based out of either our San Francisco, CA or Cambridge, MA office and will require 5% travel. 

Your work will primarily encompass: 

• Day-to-day management of vendors involved in data management, to ensure quality of deliverables and that SET timelines are met 
• Gather input from stakeholders and design data flow across data sources and across vendors 
• Develop and review study plans and protocols to ensure that data collection designs meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines) 
• Develop and review specifications for database build and validation, edit checks, external system integration, or other systems and processes related to data while enabling near-real time data access for Olema clinical trials 
• Ensure quality of clinical data by review for completeness, accuracy and consistency in accordance with study plans 
• Support SAE reconciliation between clinical and pharmacovigilance databases and external data reconciliation within the clinical database 
• Provide Clinical Data Management subject matter expertise to study team members during all phases of the project life cycle, including internal and external audits and inspections 
• Lead a team of data management professionals 
• Assist in the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements 

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 or higher in science, biology, mathematics or computer science 
• CCDM certification preferred 
• Experience across early to late-phase clinical trials preferred; late-phase oncology experience required 
• Practical knowledge of MedDRA, WHODrug and/or another controlled thesaurus 
• Knowledge of Project Management Principles; a PMP certification is a plus 
• Deep expertise in Excel and MS Office tools 
• Relational database understanding and SQL knowledge 
• Understanding of data manipulation, for example using SAS, R, or Python/Pandas 

Experience: 

• 15+ year experience in data management in clinical trial industry (med device, pharma or biotech) 
• At least 5 years of experience managing data management professionals 
• In-depth understanding of clinical and data management regulations and guidelines: ICH, GCDMP, 21CFR Part 11, GDPR and functional knowledge of CDISC/SDTM/SDTMIG standards 
• Experience managing data management CROs 
• Deep experience in reviewing clinical data 
• Hands-on deep experience working with EDC systems (e.g. Rave, Veeva,) 
• Practical experience building studies using CDISC/CDASH standard 
• Experience with data visualization tools (e.g. Spotfire, Tableau, RShiny, Dash) 
• Experience with management of data flow and curation of biomarker data a plus 
• Experience with a programming language a plus 

Attributes: 

• Excellent verbal and written communication and skills, coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision 
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines 
• A commitment to excellence 
• Collegial, hard-working, confident, a self-starter and have a passion for results 
• A fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization 
• Strong teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others 
• A demonstrated ability to make decisions in situations where there is incomplete or ambiguous information and where there is a high degree of professional judgment required 
• A “difference maker” in terms of one’s professionalism and contributions 
• Impeccable professional ethics, integrity and judgment 

The base pay range for this position is expected to be $205,000 - $220,000 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.

Fraud Alert:  We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.