Senior Director, Head of Translational Science and Biomarkers

Asher Bio

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 06/15/2021
  • Website: asherbio.com
  • Company Address:

About Asher Bio

Developer of immunotherapy drugs designed to treat cancer effectively. The company's drugs ramp up the immune system to take on cancer cells with precision with minimal side effects, enabling doctors to treat patients in a short period of time.

Job Description

Asher Biotherapeutics Inc. is a privately held, preclinical-stage immunotherapy company that is leveraging an elegant discovery platform to target immunotherapies to specific immune cell subsets.  We are building a pipeline of differentiated targeted cytokines with the potential to treat cancer as well as autoimmune and infectious diseases.  Reporting the Chief Medical Officer, the Head of Translational Medicine and Biomarkers will support this mission by building the overall translational science strategy for Asher’s development programs in coordination with clinical and development team leads.  Moreover, (s)he will oversee the development, qualification/validation and implementation of all analytical and clinical biomarkers.  
 
In this role, The Head of Translational Medicine and Biomarkers will draw on extensive experience and strong leadership and organizational skills to build a highly functional, outsourced biomarker and translational science organization from the ground up.  S/he will also work closely with all stakeholders on each development team and across the company to elaborate an integrated translational science strategy for each development program as part of the broader clinical/translational development plan for each molecule. Strategic goals will include identifying patient subgroups with a higher probability of response, pharmacodynamic markers that correlate with response, and therapeutic strategies (including combinations) that optimize outcomes for patients. 
 
This individual must therefore possess outstanding communication skills and work productively with cross-functional product teams, external consultants, CROs, external key opinion leaders, regulators, etc.  The successful candidate will take utmost care to build and nurture a strong Biomarker and Translational Science Group within Asher that will support both the scientific and operational aspects of biomarker development and bioassay implementation with the utmost rigor.  This individual will ultimately mentor and manage staff to ensure that all assays are developed and implemented in a timely manner and that assay workstreams support the highest quality biomarker data generation. The individual must be able to collaborate closely with both the preclinical and clinical research teams to integrate preclinical observations into the clinical strategy and validate and explain clinical observations in preclinical models.  The ideal candidate should possess strong leadership skills, be self-motivated, and enjoy working in a dynamic, focused biotechnology company dedicated to developing transformational therapies to care for patients.

Responsibilities

    • Working with the development team for each program, develop an integrated translational science, biomarker and assay strategy, inclusive of bioanalytical assays, key pharmacodynamic endpoint assays and other assays to support primary and exploratory biomarker-related endpoints.   The overall translational science strategy will include data science efforts and scientific and strategic partnerships relevant to answering key biological questions about mechanism of action, patient populations most likely to benefit, novel biomarkers of response, complementary therapeutic combinations, etc.
    • Support assay development and qualification/validation at external vendors.  Support seamless execution of assay work in the context of our clinical trials
    • Support implementation of high-quality sample collection, processing and tracking across all programs
    • Identify appropriate vendors and manage vendor relationships supporting all bioassay and sample management activities
    • Author relevant sections of protocols, regulatory documents, etc.  
    • Support interactions with regulatory authorities relative to the utility and performance of bioanalytical and clinical trial assays 
    • Support development and implementation of Asher Bio SOPs to ensure compliance with cGCP and GLP regulations
    • Grow and mentor the Translational Science and Biomarker Team, with a focus on career development.  Develop budgets and resource forecasts for the Translational Science and Biomarker Team
    • Communicate Asher Bio’s translational science and biomarker strategies internally and with external stakeholders.

Experience/Preferred Qualifications

    • Experience working in a highly outsourced environment and in selecting, overseeing and managing CROs.  Experience in building and/or growing a highly outsourced biomarker/assay organization highly desirable.
    • Experience with bioanalytical assay development for biologics, and with clinical assay development in oncology and/or immunology-relevant disciplines
    • Experience with biomarker operations, sample management and other aspects of biomarker program execution in the context of clinical trials
    • Comfortable with setting high-level strategy in collaboration with internal and external experts, as well as taking a hands-on approach to bioassay development and implementation activities
    • Experience interacting directly with the FDA and other health authorities is desirable
    • Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
    • Possess outstanding mentorship skills and promote the career development of members of the translational science and biomarker team
    • Self-motivated with experience in a fast-paced, mission-driven and team-oriented environment

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Senior Director, Head of Translational Science and Biomarkers

Asher Bio - South San Francisco, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.