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CONFIRM
NEW
Dec 30 — 2021

Head of Translational Medicine

Department:Clinical Development Location: Alameda, CA, USA Job Type: Full-time Reports to: Chief Scientific Officer

About the role

We are seeking a highly motivated and experienced individual with deep translational expertise to head the Translational Development team within Acepodia, in Alameda, CA.

Reporting to the Chief Scientific Officer (CSO) and in close collaboration with the Chief Medical Officer (CMO), the Head of Translational Medicine will lead a team of biomarker leads dedicated to delivering translational and biomarker strategies for the Acepodia portfolio of cell therapy programs. The Head will bring deep scientific experience with emphasis on oncology/ImmunoOncology biomarkers, in-depth knowledge of oncology, & clinical development perspective. The Head will integrate translational research and clinical development, be responsible for the design, delivery, and execution of biomarker and translational strategies from program inception through First in Human, including clinic-ready pharmacodynamic, mechanism of action, target engagement and patient selection assays and strategies, in alignment with clinical development objectives, for all Acepodia programs.

Education / Background

  • MD, PhD or MD/PhD or equivalent advanced biology degree.
  • 8+ years of industry experience in oncology drug discovery and development process, preferred within translational biomarker roles.

Responsibilities include, but are not limited to

  • Effectively partnering within the organization and acting as the key interface between groups including discovery research, translational medicine, clinical development and project leadership, and also with external partners, to deliver on the high-quality biomarker plans for all development candidate programs within Acepodia.
  • Establish and execute well-crafted translational and biomarker strategy for all development candidates within Acepodia, focused on target engagement, mechanism of action, pharmacodynamic biomarker and patient selection assays.
  • Provide guidance, oversight, scientific input, and biomarker expertise for execution, & review of all biomarker aspects of early development plans and academic collaborations including resultant publications and posters, as well as for relevant documents (such clinical protocols, sample collection tables, sample collection instructions and logistics, investigator brochures, regulatory documents, etc.)
  • Integrate translational research and clinical development, develop a biomarker strategy in alignment with clinical development objectives and lead efforts for data generation, assay development and clinical biomarker sample analysis data interpretation and communication to the development teams.
  • Proactively provide insight into novel ways to incorporate biomarkers into clinical designs, including providing insight into new technologies to support biomarker plans, to enable early understanding of emerging drug profiles as programs emerging from the research move through clinical development.
  • Ensure progress of translational plans into implementation and execution via internal technical assay execution and/or execution with external contract research organizations (CROs) and specialty testing labs.
  • Support due diligence and asset integration activities as needed.
  • Communicate key biomarker program information, risks, risk mitigations and milestones, and manage information flow across key stakeholders including therapeutic area leadership, functional leads, and team members, independently engages with development teams and technical/scientific experts to define, revise and progress biomarker plans.
  • Collaborate and strategize across the entire organization to improve efficiency and accelerate the product pipeline forward.
  • Participate in strategic overview of presentations, publications, and internal/ external communications along with accountable program leadership.

Position Requirements & Experience Relevant Skills & Experience:

  • Proven track-record in successfully managing and leading a team of scientists.
  • Documented experience in oncology/immuno-oncology drug development, deep understanding of the role of translational research/medicine and clinical biomarkers in drug development and working knowledge of all functional areas of drug development, including biology, clinical development, diagnostic development.
  • Demonstrated scientific acumen and mechanistic understanding of disease biology and experience in oncology and immuno-oncology drug development (antibodies, biologics and cell therapies).
  • Experience in the design and generation of clinic-ready biomarker assays in oncology.
  • Excellent verbal and written communication skills across all levels both within an organization and with external collaborators/companies with the ability to recognize, articulate, and accept calculated risks to make informed decisions.
  • Demonstrated ability to lead others through change by navigating ambiguity, creating the context, and engaging individuals.
  • Comfortable working in a fast-paced environment where speed is paramount.
  • Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets.
  • Experience from FIH through at least phase 2 trials, including directly contributing to translational biomarker and sample collection strategies.
  • Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies (e.g. flow cytometry, immunoassays, genomics, immunohistochemistry and multiplex approaches, etc.) and working knowledge of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, etc.
  • Working knowledge of all functional areas of drug development, including, biology, toxicology, clinical development, diagnostic development, & demonstrated scientific acumen and mechanistic understanding of disease biology.
  • Demonstrate a commitment to Acepodia values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun

Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.

About Acepodia

Acepodia is a clinical-stage biotechnology company developing NK and NK-like gamma delta T cell therapies using our patented ACC (Antibody Cell-Conjugation) technology platform. Using ACC technology, we arm immune cells with antibodies to target and eradicate cancer cells. Our mission is to develop safe, effective, and affordable cell therapies to fight and beat cancers.

Founded in 2017 in the birthplace of biotechnology, the San Francisco Bay Area, CA. Acepodia is venture capital and private equity backed and funded. Our platforms and products aim to address and overcome the major obstacles in cancer therapy: Ability to target low expression of tumor antigens to better prevent tumor escape; Trafficking of effector cells to tumor locations; Activate the immune system to attack cancer cells.
 

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