San Francisco, United States

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 3 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.

The Role:

We are seeking an experienced, driven colleague to lead our analytical development and quality control effort. This role will report to the Senior Director, Analytical Chemistry and will be responsible for driving progress of both early- and late-stage molecules by delivering phase-appropriate analytical methods and validation.

This is a fantastic opportunity for a hands-on Director, Analytical Chemistry to join a company with an industry leading Board of Directors and Management team. This analytical chemistry leader will roll up their sleeves to help build and grow an innovative women’s oncology company with significant potential to transform breast cancer treatments.

This position is available in our San Francisco office.

What You Will Do:

Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
Author appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
Represent Analytical Chemistry at internal and external scientific team meetings as needed
Remain current with state-of-the art approaches and applicable global regulations and industry standards

What You Will Bring:

PhD with 10 years or MS with 15 years of relevant industry experience and exposure to small molecule drug substance analytical development and quality control, including late-stage clinical development and preparation for product registration
Minimum 5 years direct leadership experience on managing internal and external teams
Expertise in analytical development and quality control for both drug substance and drug product
Knowledge of cGMP, ICH, and FDA regulations/guidance
Experience authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects

Personal Characteristics:

Given the “small biotech” nature of the Company, the overall cultural add of the successful candidate is an important criterion for their success at Olema. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job.

Specific personal characteristics include:

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 deadline
A commitment to excellence
Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
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 on incomplete information and in areas where a high degree of professional judgment is required
Be a “difference maker” in terms of one’s professionalism and contributions
Have impeccable professional ethics, integrity and judgment
Be collegial, hard-working, confident, a self-starter and have a passion for results

The base pay range for this position is expected to be $218,000 - $230,000 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-MK1

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.

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