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    Non-Clinical Operations Manager - San Francisco, United States - Olema Oncology

    Olema Oncology
    Olema Oncology San Francisco, United States

    3 weeks ago

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    Description
    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 , 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 Non-Clinical Operations Manager will support all nonclinical activities in Pharmacology, DMPK and Toxicology functions for Olema Oncology ranging from early candidate nomination, IND/CTA-enabling, and NDA/MAA-supporting studies.

    This role reports to the Vice President of Non-Clinical Pharmacology and Toxicology.


    Job Responsibilities:


    Coordinate nonclinical activities for Olema Oncology's programs by facilitating preparation of statements/scope of work documents, contract approvals, ensuring efficient review of protocols and reports, and driving nonclinical activities to support development candidate nomination, IND/CTA, post-IND regulatory nonclinical activities and NDA/MAA filing.

    Maintaining the overall schedule of nonclinical studies system to track the entire workflow of nonclinical studies and archival of study-related materials; collaborate with the Biology, Medicinal Chemistry, and CMC leads to create and maintain timelines for nonclinical studies.

    Develop and implement new processes and procedures to support both regulatory compliance and efficiency across nonclinical functions.
    Review, maintain and update databases for DMPK, Pharmacology and Toxicology data.

    Facilitate CRO vendor selection with negotiating contracts and approval; establish list and consulting agreements for consultants with relevant and specialized subject matter expertise; participate in quarterly budget reviews.

    Support the review of nonclinical sections for regulatory submissions and amendments; maintain study-specific templates for eCTD tabulated summaries; and verify electronic data packages for regulatory submission (SEND).

    Serve as liaison between Research and CMC groups to ensure Certificates of Analysis and stability for toxicology lots is maintained and represent Research in periodic stability updates.

    Apply project management and technical expertise to monitor critical path timelines and resources.
    Demonstrate excellent leadership skills to tactfully influence individuals at all levels of the organization.


    Job Requirements:
    BA/BS in a scientific or technical field.
    Experience as Non-Clinical Operations Manager in Pharmacology, DMPK and/or Toxicology.
    Experience with data analysis and interpretation of nonclinical data.
    7+ years of relevant industry experience.
    Meticulous document management practices and organizational skills.
    Project management experience is a plus.
    Successful performance managing multiple tasks and projects.


    The base pay range for this position is expected to be $140,000 - $165,000 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-EC1

    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 .
    #J-18808-Ljbffr
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