Sr. Director, Preclinical

Vedere Bio II

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 04/01/2021
  • Website: www.vederebio.com
  • Company Address: 400 Technology Square 10th Floor, Cambridge, MA, 02139

About Vedere Bio II

Comprised of a diverse team of pioneering scientists, Vedere Bio is discovering and developing next generation ocular gene therapies to make vision restoration a reality. With our ocular gene therapy toolbox, we are focused on high-quality vision restoration and vision preservation to bring life-changing technology to patients around the world.

Job Description

Vedere Bio II, Inc. (Vedere) is a stealth-stage company being incubated at Atlas Ventures, which is also one of the Company’s investors.  Vedere seeks an experienced head of Preclinical Development to provide strategic and operational leadership for the preclinical development strategy. The ideal candidate will thrive in a fast-paced startup focused on gene therapies and other modalities to develop vision restoration and vision preservation therapies for patients with vision loss around the globe.

We want to work towards making an impact with you!

The Position: Sr. Director, Preclinical

Responsibilities:

  • Head of non-clinical safety, responsible for DMPK, and pre-clinical translational studies to support clinical development, including non-rodent (NHP) studies

  • Develop overall preclinical safety evaluation and translation strategy for Vedere pipeline

  • Work closely with discovery and pre-clinical stage program teams to establish strategy and non-clinical safety and pre-clinical translational study designs

  • Work closely with development stage program teams to drive non-clinical safety that supports clinical advancement (chronic toxicity, carcinogenicity and DART assessments) leading to regulatory interactions for later stage studies and registration

  • Study and data interpretation, document authoring, IND writing and regulatory interactions

  • Evaluation of in-licensing opportunities

  • Serve as the internal expert for the design of project-specific strategies to predict, assess and mitigate target- and treatment-related safety risks; provide expert opinion on non-clinical safety and risk assessment to senior management

  • Develop and oversee toxicology studies

  • Generate, analyze and present data, both orally and as written reports; deliver presentations internally or externally as needed

Qualifications:

  • PhD in toxicology or related field or DVM with minimum of 10 years of relevant industry experience

  • Expertise in technical, scientific, and regulatory aspects of non-clinical safety evaluation of AAV gene therapies

  • Proven ability to design, manage and interpret outsourced non-clinical safety studies in rodent and non-rodent (NHP) species

  • Demonstrated ability to tackle complex scientific problems to enable first in man dosing or progression of programs into late-stage development

  • Previous experience having progressed AAV gene therapy into first in man (IND) is a must

  • Previous experience having progressed small molecules or biologics through clinical development or registration is a plus

  • Comprehensive understanding of the interplay between non-clinical safety, pharmacology, biomarkers, DMPK and formulations

  • Experience with investigative toxicology including proven ability to research and develop strategy around novel findings

  • Extensive experience interfacing with, and providing scientific guidance to, CRO partners and proven ability to work efficiently in a hybrid model

  • Experience interacting with worldwide regulatory agencies and authoring regulatory filings

  • Proven success in supporting cross-functional project teams and ability to collaborate in a cross-functional matrixed organization

  • Strong oral communication skills and demonstrated proficiency at technical writing are essential

  • Ability to integrate data across disciplines and communicate salient data to executive leadership and/or a broad audience

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.


No Employment Agencies please, the Company is not responsible for any fees related to candidates that are unsolicited.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.