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Senior Director, Regulatory Affairs CMC

Employer
Olema Oncology
Location
San Francisco, California
Start date
Feb 20, 2024

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Who We Are >>> Why You Should Work With Us

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer. 

Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses. 

While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.  

About the Role >>> Senior Director, Regulatory Affairs CMC 

As the Senior Director, Regulatory Affairs CMC reporting to the VP, Regulatory Affairs and Quality Assurance you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will ensure these strategies are aligned with Health Authority requirements globally and provide guidance and oversight for development of high quality and on-time CMC sections of the regulatory submissions. You will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization. 

This role is based out of our San Francisco, CA  or Cambridge, MA office and will require 10% travel. 

Your work will primarily encompass: 

  • Provide CMC regulatory expertise and leadership for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs). 
  • Lead negotiations with regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions with regulators globally (US, EU and Japan) for initial INDs/CTAs, marketing registration applications, supplements and variations. 
  • Provides strategic regulatory CMC direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management and Health Authority interactions.  
  • Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner.  
  • Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports. 
  • Collaborate effectively with internal and external teams (CMC, QA, Supply Chain, RA etc).  
  • Be responsible for planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities and working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners.  
  • Maintain responsibility for all CMC Regulatory timelines. 
  • Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.
  • Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. 
  • Support interactions with regulatory agencies during inspections. 
  • Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs. 

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, preferably in a scientific field; advanced degree is a plus. 
  • 15+ years of drug development, including 10+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry. 
  • Expert knowledge of current CMC regulations and regulatory procedures. 

Experience: 

  • Experience in small molecule drug development required; experience in the oncology therapeutic area is a plus.  
  • Global CMC regulatory experience is required. 
  • Post approval (commercial) experience is a plus. 
  • Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP. 
  • Experience with eCTD requirements and electronic submissions.  
  • Experience with international regulatory submissions and processes is a strong plus. 

Attributes: 

  • Strong business acumen and ability to successfully work with international and cross functional partners.  
  • Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.  
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.  
  • Excellent verbal, written and presentation skills.   
  • Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.  
  • Fosters open communication. Listens and facilitates discussion. 

The base pay range for this position is expected to be $260,000 - $275,000 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

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.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

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.

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