GenEdit is a rapidly growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload, formulation, screening, and preclinical groups to develop the next generation of gene therapies. GenEdit fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and be at the forefront of gene delivery and therapy.
We are seeking a Senior Consultant, PK/PD & ADME to join our cross-functional discovery teams and create transformative therapeutic drug candidates. This is a part-time role supporting GenEdit 20-30 hours per month.
Responsibilities
•Technical Guidance: lead and support PK & ADME research activities related to GenEdit’s hydrophilic nanoparticle (HNP) therapeutic drug candidates.
•Develop and coordinate PK & ADME strategy, experimentation, implementation and data analysis.
•Identify CROs/CDMOs, develop study plans, coordinate study execution, and communicate results to GenEdit’s leadership.
•Use preclinical data including pharmacology, PK/PD and ADME to predict human efficacious dose.
•Project Leadership
•Regulatory Support
•Project and Risk Management
Qualifications
•PhD degree in pharmacokinetics/pharmacodynamics, clinical pharmacology or a closely related discipline with a minimum of 10 years of relevant experience in the pharmaceutical or biotech industries.
•Experience with PK & ADME approaches for RNA therapeutics and nanoparticle delivery technologies in drug discovery programs preferably through IND filing.
•Preferred experience working with polymeric nanoparticles, PLGA-PEG, LNP and/or lipoplex for nucleic acid delivery.
•Familiarity with regulatory requirements and guidelines for nanoparticle drug product PK & ADME.
•Experience with mathematical QSP and PK/PD modeling a plus.
•Desired skills and behavioral competencies
•Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation.
•Ability to build strong relationships and collaborate effectively with other interfacing GenEdit functions.
•Comfortable challenging the status quo and bringing forward innovative solutions.
•Ability to take risks implementing innovative solutions.
•Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
•Excellent written and verbal communication skills in English.
The position will be based in GenEdit headquarters in Brisbane, CA.
At GenEdit we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world.
Top Skills
What We Do
GenEdit is focused on overcoming the major challenge to genetic medicines: Delivery. We aim to overcome this limitation and enable treatment of a broad range of diseases, having a positive impact on the lives of as many people as possible.
The foundation of our company is our NanoGalaxy platform. NanoGalaxy contains a library spanning thousands of unique non-viral, non-lipid, polymer nanoparticles. Using our iterative screening process, we are able to identify polymer nanoparticles that can deliver the needed genetic medicine payload to the needed tissue to treat disease.
We are focusing our research on the treatment of diseases for which our delivery technology can enable therapeutic options that otherwise may not be possible. We are developing an internal pipeline of therapeutic candidates to treat a range of diseases with high unmet medical need.
