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    Sr/Exec Dir, Process Research - Boston, MA, United States - Kura Oncology, Inc.

    Kura Oncology, Inc.
    Kura Oncology, Inc. Boston, MA, United States

    3 weeks ago

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    Description
    Sr/Exec Dir, Process Research & Development and Manufacturing

    Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

    At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

    As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

    To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude.

    Independently design synthetic routes to target molecules, conduct Process Research and Development, and manage API process research and development projects to develop cost-efficient, scalable and robust drug substance manufacturing processes.

    Establish drug substance (including the related raw materials and intermediates) development manufacturing routes and strategies.

    Provide strategic planning as well as technical support and oversee and manage contract manufacture organization (CDMO's) to prepare manufacturing batches, development reports and other development-related documents.

    Guide external third parties through technology transfer, process development, optimization, qualification and validation of the activities related to DS manufacturing operations.

    Collaborate with other functions to assure compliance with applicable GMP and global regulatory requirements.
    Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
    Provide technical strategic support and documentation for answering questions during regulatory submission reviews.
    Supervise and manage CMC chemists and related staff.
    A minimum of 12+ years' industry experience in process research and development and CDMO management.
    Strong knowledge of drug substance process development and manufacture for early development. Knowledge of late development such as process registration, validation, and launch, a plus.
    Excellent planning and organizational skills.
    Able to make international and domestic travels.
    Experience with managing outsourced projects with contractors.

    The base range for a Senior Director is $250,000 - $280,000 and Executive Director is 275,000 - $295,000 per year.

    Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training.

    Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.
    Kura's Values that are used for candidate selection and performance assessments:
    Generous stock options
    ~ 18 Holidays (Including Summer & Winter Break)
    ~ In-Office Catered lunches
    ~ Home Office Setup
    ~ Commuter Stipend (Boston Office)
    ~ The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives.

    Kura's pipeline consists of three investigational drug candidates:
    ziftomenib, tipifarnib and KO-2806.

    Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.

    For additional information, please visit Kura's website at .

    All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

    Are you open to considering relocation to Boston?

    Are you open to considering relocation to San Diego?

    Will you now or in the future require sponsorship for employment to work in the United States?

    For government reporting purposes, we ask candidates to respond to the below self-identification survey.

    As set forth in Kura Oncology's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

    If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.

    As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.


    A "disabled veteran" is one of the following:
    a veteran of the U.S.

    military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

    A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.

    military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order
    Voluntary Self-Identification of Disability
    For government reporting purposes, we ask candidates to respond to the below self-identification survey.

    As set forth in Kura Oncology's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

    Race & Ethnicity Definitions

    If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.

    As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.


    A "disabled veteran" is one of the following:
    a veteran of the U.S.

    military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

    A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.

    military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order
    Veteran Status Please select Veteran Status Voluntary Self-Identification of Disability
    We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. Your answer is confidential.

    If you want to learn more about the law or this form, visit the U.Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at .

    How do you know if you have a disability? A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability.


    Disabilities include, but are not limited to:
    Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
    Diabetes
    Epilepsy or other seizure disorder
    Intellectual or developmental disability
    Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
    Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
    Disability Status Please select Disability Status


    PUBLIC BURDEN STATEMENT:

    According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number.

    This survey should take about 5 minutes to complete.
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