Full-Time

Director – CMC Drug Substance Manufacturing

Olema Oncology

Olema Oncology

51-200 employees

Clinical-stage biopharma targeting ER-positive breast cancer

No salary listed

Dublin, Ireland

In Person

Category
Biology & Biotech (3)
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Required Skills
REST APIs
Requirements
  • Ph.D. in Organic Chemistry or related discipline with ~10+ years of experience (or M.S. with ~15+ years) in small molecule CMC drug substance development and manufacturing
  • Demonstrated experience leading technology transfer, scale-up, and validation of API processes to GMP manufacturing sites for late-stage and commercial programs
  • Strong experience managing CDMOs, including vendor selection, technical oversight, and delivery of manufacturing campaigns aligned with quality, timeline, and cost objectives
  • Proven success authoring and reviewing CMC sections of INDs, IMPDs, and NDAs/MAAs, and supporting regulatory interactions and responses with health authorities
  • Strong technical foundation in small molecule process development, manufacturing, and control strategy, including DOE, PAR, and impurity control (e.g., fate and purge)
  • Deep understanding of cGMP requirements and global regulatory expectations (ICH guidelines), with experience supporting inspection readiness and compliant manufacturing execution
  • Demonstrated ability to identify technical risks and apply risk-based decision-making to drive timely and practical solutions
  • Experience integrating process and manufacturing data to support process understanding, trend analysis, and continuous improvement
Responsibilities
  • Lead technology transfer of drug substance processes (RSM/API) to CDMOs, including strategy, execution, and risk management to support late-stage development and commercial manufacturing
  • Provide technical oversight of CDMO activities, including process validation, manufacturing campaigns, and on-site support; serve as the primary technical point of contact
  • Review and approve key manufacturing and development documentation (batch records, protocols, reports, specifications, and deviations) to ensure compliance and data integrity
  • Lead deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs) to support reliable manufacturing performance
  • Drive process robustness, control strategy development (e.g., DOE, PAR), and PPQ readiness to enable successful validation and commercial supply
  • Leverage process and manufacturing data to enhance process understanding, monitor performance across sites, and identify opportunities for continuous improvement
  • Support commercial supply readiness, including supply continuity, cost of goods optimization, and lifecycle management activities
  • Author and review CMC sections of IND/NDA submissions, and support regulatory interactions and responses, and inspection readiness
  • Identify technical risks and proactively develop mitigation strategies to ensure timelines for NDA filing and commercial launch are achieved
  • Partner cross-functionally with Quality, Regulatory, Analytical, Drug Product, and Supply Chain to ensure aligned execution and compliance with global regulatory requirements
Desired Qualifications
  • Curious, scientifically rigorous, and proactive with a strong “can-do” mindset
  • Self-motivated and accountable, able to work independently and drive results
  • Effective collaborator across cross-functional teams and external partners
  • Highly analytical and detail-oriented, with a data-driven approach
  • Organized and execution-focused, able to manage multiple priorities and timelines
  • Committed to high scientific, quality, and ethical standards while driving continuous improvement

Olema Oncology develops targeted therapies for women’s cancers, with a focus on ER+/HER2- breast cancer. Its lead candidate palazestrant (OP-1250) is a dual CERAN/SERD that blocks estrogen signaling and promotes estrogen receptor degradation. The company is running a Phase 3 trial of palazestrant in combination with CDK4/6 inhibitors and has a collaboration with Novartis to test the therapy with ribociclib and everolimus. A second program, a KAT6 inhibitor, is in preclinical development, targeting epigenetic regulation.

Company Size

51-200

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2007

Simplify Jobs

Simplify's Take

What believers are saying

  • OPERA-01 Phase 3 pivotal data readout expected Fall 2026 validates monotherapy efficacy.
  • $218.5 million raised November 2025 funds through Phase 3 completion and commercialization.
  • Pfizer supplies atirmociclib for Phase 1b/2 palazestrant combo in ER+/HER2- breast cancer.

What critics are saying

  • OPERA-01 monotherapy fails Fall 2026 readout, collapsing stock before OPERA-02 data.
  • CFO Shane Kovacs departed January 2026, misallocating $218.5 million capital without replacement.
  • MPM BioImpact exited entire position Q3 2025, signaling institutional doubt in palazestrant.

What makes Olema Oncology unique

  • Palazestrant uniquely blocks ER AF1 and AF2 domains, inhibiting transcription regardless of ESR1 mutations.
  • Palazestrant synergizes with OP-3136, downregulating proliferation and metastasis gene signatures preclinically.
  • OP-3136 selectively inhibits KAT6 for ER+ breast, prostate, and lung cancers in Phase 1.

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Benefits

Health Insurance

401(k) Retirement Plan

Remote Work Options

Paid Vacation

Flexible Work Hours

Hybrid Work Options

Stock Options

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

Professional Development Budget

Conference Attendance Budget

Development Training Programs

Tuition Reimbursement

Professional Certification Support

Adoption Assistance

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Relocation Assistance

Bonus

Equity

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

0%
BioWorld
Apr 10th, 2026
Aurigene Oncology and Olema Pharmaceuticals patent KAT6A degradation inducers.

Aurigene Oncology and Olema Pharmaceuticals patent KAT6A degradation inducers. April 10, 2026 Aurigene Oncology Ltd. and Olema Pharmaceuticals Inc. have disclosed new proteolysis targeting chimera (PROTAC) compounds comprising an E3 ubiquitin ligase CBL-B (CBLB)-binding moiety coupled to a histone acetyltransferase KAT6A (MOZ; MYST-3)-targeting moiety. They are described as potentially useful for the treatment of cancer.

Nasdaq
Mar 18th, 2026
Biotech Stock Up Nearly 300% Draws $68.7 Million Bet as Breast Cancer Drug Targets 2027 Launch

Key PointsCormorant Asset Management established a new stake in Olema Pharmaceuticals, purchasing 2,750,000 shares in the fourth quarter. |

GlobeNewswire
Mar 17th, 2026
Olema Oncology to present preclinical data for palazestrant and OP-3136 at the 2026 AACR Annual Meeting.

Olema Oncology to present preclinical data for palazestrant and OP-3136 at the 2026 AACR Annual Meeting. March 17, 2026 16:30 ET | Source: Olema Oncology SAN FRANCISCO, March 17, 2026 (GLOBE NEWSWIRE) - Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it will present two preclinical posters at the American Association for Cancer Research (AACR) Annual Meeting taking place April 17-22 in San Diego, California. Poster Presentation Details Title: Palazestrant directly recruits the corepressor protein NCoR1 in vitro leading to complete antagonism of estrogen receptor alpha Poster/Abstract: 2950 Session: Experimental and Molecular Therapeutics: Cellular Responses to Anticancer Drugs Date/Time: April 20, 2026, from 2:00-5:00pm PT / 5:00pm-8:00pm ET Title: Palazestrant, a CERAN, in combination with OP-3136, a KAT6 inhibitor, synergistically downregulates cell proliferation and metastasis related gene signatures Poster/Abstract: 2949 Session: Experimental and Molecular Therapeutics: Cellular Responses to Anticancer Drugs Date/Time: April 20, 2026, from 2:00pm-5:00pm PT / 5:00pm-8:00pm ET About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (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. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136 OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "anticipate," "believe," "could," "expect," "goal," "intend," "may," "on track," "potential," "upcoming," "will" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant or OP-3136, the combinability of palazestrant or OP-3136 with other drugs, including in the metastatic setting, and the timelines for enrollment for current clinical studies and for the receipt and presentation of results of clinical trials of palazestrant and OP-3136 each as a monotherapy and in combination trials. Because such statements deal with future events and are based on Olema's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled "Risk Factors" in Olema's Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O'Konek Vice President, Corporate Communications Olema Oncology [email protected]

Yahoo Finance
Jan 31st, 2026
Olema Oncology CFO Shane Kovacs departs after six years with company

Olema Oncology, a clinical-stage biopharmaceutical company focused on breast cancer therapies, announced that Shane Kovacs, Chief Operating and Financial Officer, is leaving the company effective 30 January 2026 to pursue new opportunities. Kovacs will continue as a consultant through 1 August 2026. Kovacs joined Olema in 2020 and helped lead the company through late-stage clinical development of its lead candidate palazestrant whilst building the finance team and establishing a strong capital position. CEO Sean Bohen thanked Kovacs for his contributions and commitment. The company will immediately begin searching for a new Chief Financial Officer. Bohen will serve as interim Principal Financial Officer until a successor is appointed.

Insider Monkey
Jan 30th, 2026
LifeSci Capital Reiterates a Buy on Olema Pharmaceuticals (OLMA)

LifeSci Capital reiterates a Buy on Olema Pharmaceuticals (OLMA). Published on January 30, 2026 at 9:47 am by talha qureshi in news. Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) is one of the Best Small Cap Stocks Ready to Explode in 2026. On January 26, Sam Slutsky from LifeSci Capital reiterated a Buy rating on the stock and raised the price target from $39 to $45. Earlier, on January 14, Kelsey Goodwin from Piper Sandler reiterated a Buy rating on Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) with a price target of $40. Analysts at Piper Sandler noted that the bullish rating is based on the company's Palazestrant. Palazestrant is a potential best-in-class for treating ER+/HER2- breast cancer. The firm highlighted the drug's complete ER antagonism and ER degradation ability. These capabilities are expected to make the drug an upcoming treatment in the huge breast cancer market. In addition, the firm highlighted that the company is expecting multiple phase 3 trials in 2026, which are expected to add further upside to the stock. Piper Sandler expects Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) to launch Palazestrant by next year. Olema Pharmaceuticals, Inc. (NASDAQ:OLMA) is focused on the development of treatments for patients with breast cancer and other serious diseases. Its key pipeline includes Palazestrant and OP-3136. While we acknowledge the potential of OLMA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than OLMA and that has 100x upside potential, check out our report about this cheapest AI stock. Disclosure: None. This article is originally published at Insider Monkey.