Associate VP / Sr. Director of Translational Sciences - Pasadena California

Company: AcuraStem Inc.
Location: Pasadena, California
Posted On: 02/02/2025

Associate VP / Sr. Director of Translational SciencesAcuraStem is a patient-based biotechnology company pioneering the development of treatments for amyotrophic lateral sclerosis (ALS), Frontotemporal dementia (FTD), and additional neurodegenerative diseases.We are a purpose-driven company on a mission to get our promising treatments into patients' hands as quickly as possible.AcuraStem's best-in-class disease modeling platform, iNeuroRx, is the gold standard for discovering novel, effective, and broadly-acting treatments. The AcuraStem team's extensive expertise in ASO technology is accelerating the advancement of treatments to the clinic.At AcuraStem, we know that empowered and supported colleagues strengthen our commitment and significantly enhance our collective mission. We're dedicated to fostering a culture of equality, inclusion, and mutual respect. By creating an environment where everyone feels valued and motivated to excel, we can achieve exceptional outcomes, together.Position Overview:We are seeking an experienced and driven professional to join our team as an Assistant VP or Senior Director of Translational Sciences. The ideal candidate will have a strong background in translational sciences focusing on biomarker assay development and validation, data analysis, and regulatory expertise, ideally within the neurodegenerative or oligonucleotide therapeutics fields. This role is a Full-Time Regular role and requires hands-on, in-depth experience managing translational science projects.Key Responsibilities:

• Lead Translational Science Projects: Oversee interdisciplinary teams on assay development, data analysis, and regulatory submissions. Work closely with internal and external partners to ensure successful project execution.
• Develop and Validate Biomarker Assays: Manage the creation and validation of clinical biomarker assays to support AcuraStem's drug development goals. Ensure accuracy and reliability of biomarker data through analytical and clinical validation processes.
• Analyze Biomarker Data: Produce and present data reports to support clinical strategy and decision-making and influence clinical development programs.
• Regulatory Submissions: Prepare and manage the relevant sections of regulatory documentation for key project milestones, including pre-IND, IND, and other clinical trial stages.
• Manage CRO and External Partnerships: Identify and oversee external partners (CROs, academic institutions) to support preclinical PK/PD, toxicity, biomarker, clinical validation and clinical sample analysis work. Resolve project challenges and maintain clear communication with external stakeholders.Education and Experience: Ph.D. or equivalent experience with an advanced degree in a relevant scientific field (e.g., neuroscience) with 10+ years of experience in biotech/pharma.Skills:
  • People Management - Experience leading interdisciplinary teams in regulated settings, with a focus on collaboration and effective team dynamics. Strong people management experience in regulated environments.
  • Biomarker Assay Development and Validation - Strong expertise in developing and validating pharmacodynamic (PD), pharmacokinetic (PK), and prognostic biomarker assays for clinical application.
  • Proficiency in multiple assay formats (e.g., Simoa, LCMS, ELISA, ddPCR) with hands-on experience in both analytical and clinical validations.
  • Data Analysis and Reporting - Skilled in analyzing biomarker data and producing reports that guide decision-making.
  • Regulatory Expertise - Familiarity with regulatory processes, including pre-IND, IND, Phase I/II, and ideally BLA/NDA stages.
  • CRO and Consultant Management - Proven experience managing CROs, academic collaborators, and consultants, particularly for preclinical studies, toxicity studies, PK/PD, and biomarker development.
  • Communication and Presentation skills - Excellent communication and presentation skills, with the ability to produce clear and comprehensive scientific reports and presentations.Highly Preferred Experience:
    • Background in neurodegenerative diseases or oligonucleotide therapeutics is advantageous, though not required. Experience in biotech/pharma for in-depth translational project management.
    • Experience managing in vivo studies to support assay development and biomarker discovery efforts.The salary range for this position is $200,000 - $250,000 with actual compensation determined by factors such as experience, qualifications, location, and other role-specific requirements.AcuraStem offers a comprehensive and competitive benefits package tailored to attract top talent. All regular-status employees receive compensation, performance-based bonuses, equity, and extensive benefits, including health, dental, vision, life, and disability insurance. AcuraStem also provides paid time off, annual company holidays, 401K matching, and weekly lunch for onsite staff.Diversity, Inclusion, and Recruitment Practices at AcuraStem:Applicants must be authorized to work in the United States. AcuraStem is an equal-opportunity employer and values diversity and inclusion throughout the hiring process. Employment decisions are made based on relevant qualifications, experience, and business needs, without regard to race, color, religion, sex, gender identity, sexual orientation, age, marital status, national origin, disability, veteran status, or any other protected characteristic.AcuraStem's commitment to diversity and inclusion extends to all areas of employment, including hiring, compensation, performance evaluations, promotions, training, and career development. We strive to provide a supportive and inclusive workplace, free from discrimination or harassment.
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