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Astellas Pharma Clinical Science Lead in Alameda, California

About Us:

iota Biosciences is a well-funded medical device startup dedicated to bringing novel bioeletronic devices to market. I. Bioelectronic devices are the start of a an entirely new form of medicine, where miniature devices treat chronic diseases through mechanisms like electrical stimulation or targeted chemical release, or collect disease diagnostics at a specificity or frequency not previously possible.

Iota's core technology stack enables a custom ultrasound wand to communicate with and power custom implantable devices, eliminating the need for wires or batteries and making it possible to produce tiny medical implants. This product concept is based on the ground-breaking "neural dust" technology initially developed at UC Berkeley. From this academic proof of concept, iota Biosciences is developing a family of miniscule yet effective and manufacturable medical products.

At iota Biosciences you will be given the opportunity to substantially influence the design and success of Class III medical devices. This opportunity is unique to early-stage startups. Join our team and participate in delivering new effective therapeutic options to patients with hard-to-treat conditions.

iota Biosciences is based in Alameda, California. For more information please visit iota.bio

Clinical Science Lead:

The Clinical Science Lead (CSL) is a professional who will serve as a key scientific partner between healthcare providers and internal iota colleagues. The CSL will provide clinical support to internal cross-functional teams, help establish advisory boards and provide clinical study support for iota projects. The CSL will ensure access to current medical and scientific information on currently marketed therapies in specific areas of interest (Opthamology, Urology, Oncology, Immunology or Neurology).

In addition, the CSL will assist with Early Feasibility clinical trial set up and execution. The CSL will be a conduit between clinical operations and the clinical site to ensure appropriate engagement and build foundational relationships. The CSL may also be involved with site initiation, site education, and relationship management in providing clinical protocol, clinical trial data and disease expertise to clinical investigators, nurses and health care providers involved in clinical studies.

Core skill sets/responsibilities:

  • Maintains in-depth scientific knowledge in relevant therapeutic areas

  • Delivers clinical value propositions and engages with key opinion leaders in medical groups

  • Provides scientific/clinical input for product requirements, user needs and risk assessment for iota's devices

  • Serves as a scientific expert at key medical and scientific advisory boards, clinical investigator meetings, and internal meetings.

  • Collects, analyzes, and communicates information concerning therapeutic area, treatment options, emerging standards of care, and competitive intelligence

  • Provides effective clinical presentations to internal and external audiences and tailors presentations to meet specific audience needs through peer to peer scientific exchange

  • Assesses feasibility and serves as the primary liaison between iota and investigator for Early Feasibility Study (EFS) protocol.

  • Operates at the highest level of iota/Astellas compliance and professional standards

Requirements

  • Doctorate degree (PharmD, MD, DO or PhD) in a relevant field (Opthamology, Urology, Oncology, Immunology or Neurology)

  • Experience in reviewing and/or writing of clinical protocols

  • Post professional degree practice or relevant transferable experience (clinical practice, academic research, regulatory/scientific) is preferred

  • Strong-track record of fostering relationships and demonstrated ability to identify national, regional, and local KOLs

  • Basic business acumen with a solid understanding of the medical device industry

  • Basic knowledge and understanding of clinical trials

  • Ability to clearly articulate complex scientific concepts in 1:1 and group settings

  • Strong interpersonal skills and excellent verbal and written communication skills

  • Creative approach to problems solving and able to work effectively in a constantly changing environment

  • Must be a strong team player and effectively interface with other internal departments including regulatory, quality, product development, and clinical operations

Job Type: Remote, Full-time or Part-time

Company Benefits:

Iota offers a very competitive benefits package that includes the following:

  • 100% employer paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, vision, and ADD. Iota covers dependents at 100%.

  • Short-Term and Long-Term Disability

  • EAP

  • 401k plan -- matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation.

  • Bonus Plan

  • Long Term Incentive Plan (LTIP)

  • 4 weeks of vacation, 2 floating holidays, and 9 Company paid holidays!

#LI-LK

Category Research and Development

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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