Director CMC, Program Management

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 >>> Director CMC, Program Management

As the Director CMC, Program Management reporting to the Vice President of Program Management, you will have both early and late phase pharmaceutical program management experience that includes knowledge of the drug development process and inter-dependencies of key functions including, but not limited to: Clinical Development, Clinical Operations, Research, Regulatory, Clinical Pharmacology, Medical Affairs, Biostatistics, Manufacturing and external collaborators. Proven experience leading the Program Management effort on filing New Drug Applications (NDAs) is a must. The Director, Program Management, will also have demonstrated success in managing programs using best-in-class methodologies and software combining strong foundational knowledge of various segments of the life sciences industry. The ideal candidate will have strong analytical thinking capabilities, refined communication and team building skills and the ability to thrive in a fast-paced, dynamic, and highly collaborative environment] 

This role is based out of our San Francisco or Boston office and will require minimal travel. 

Your work will primarily encompass:

Leading and Organizing Cross-Functional Activities  

• Collaborate with the CMC, Supply Chain, QA and CMC RA leaders and functional members to develop and execute integrated project plans to meet project goals and company goals 
• Provide support for all CMC activities, across multiple programs for PM
• Facilitate cross functional team meetings to drive effective decision making, scenario planning and risk management
• Identify critical path activities, and resource constraints, risks and conflicts that could impact the schedule, timelines and costs 
• Effectively communicate program strategies, critical path activities, timelines, risks, assumptions, alternative scenarios, and budget to internal stakeholders including Product Team(s) and the Executive Committee
• Lead the preparation of the presentations to governance committee meetings, as needed
• Ensure alignment on program strategies and project plans with internal stakeholders and resolve conflicts if necessary
• Provide program leadership with insight into team dynamics to avoid conflicts and ensure all team’s perspectives are considered
• Provide program management expertise for project managers across multiple projects that may include external co-development partnerships with vendors and CSMOs

Preparing Technical Reports and Other Written Communications (Summaries, Protocols, and Quantitative Analyses) 

• Draft and ensure the timely distribution of agendas and meeting minutes 
• Track and follow up on action items, issues and decisions, risks and mitigations, and lessons learned 
• Prepare presentations in PowerPoint with project tracking information and status updates 
• Provide appropriate metrics to demonstrate project/program progress 
• Build summary reports as appropriate for Senior Leadership 
• Ensure monthly project reports, metrics and budget numbers are tracked and reported on time and appropriately escalate deviations to management 

Planning and Directing Implementation Efforts 

• Act as an advisor to meet competing schedules and resolve team technical problems 
• Follow up on project status and issues 
• Serve as PM representative on CMC sub-teams, ensuring approved timelines and budget are on track 
• Appropriately escalate risks and mitigations to management 

Ideal Candidate Profile >>> Self-Motivated Communicator with Biotech Experience

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: 

• Master’s Degree in Life Science or Business disciple; equivalent experience may be accepted 
• Demonstrated excellence in written and oral communication skills, required 
• Excellent computer skills - including Smartsheet, MS Word, Excel, and PowerPoint, required 
• People Management experience, required 3+ years 
• Planning for commercialization and registrational batches, required 
• Coursework in project management a plus 

Experience: 

• 15+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry, including experience with both early and late phase pharmaceutical Program Management including IND/CTA, NDA/MAA submissions
• CMC experience in late-stage development and commercialization required  
• Experience with project management tools including:  PowerPoint, Smartsheet, etc. experience required 
• Demonstrated leadership and organizational skills 
• Strong ability to build cross-functional relationships with proven ability to lead and influence colleagues across the organization and with partners to achieve company goals 

Attributes: 

• Strong attention to detail 
• Excellent written and oral communication skills 
• Self-starter who thrives in a fast-paced environment 
• Passionate about the drug-development process 
• Positive attitude 
• Best work done as part of a team 

The base pay range for this position is expected to be $230,000 - $255,000 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.