Principal Scientist, Toxicology

Job Title:

Principal Scientist, Toxicology

Location:

San Diego, CA

Position type:

FLSA:

Full time

Exempt

Department:

Development Sciences

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

Avidity Biosciences is looking for an experienced scientist with a strong research background and drug development experience with proven ability to plan and execute nonclinical development strategy to advance programs from research to early and late clinical development. Ability to collaborate with multidisciplinary teams to understand the pharmacologic/toxicologic mechanism(s) of drug-induced responses is a key attribute.  The best candidate for this position can understand complex biologic pathways across multiple programs and identify key preclinical knowledge gaps to inform drug candidates' pharmacology and safety profile. 

What You Will Contribute

• Key contributor to multidisciplinary R&D teams to represent the toxicology function and define, drive, and implement nonclinical safety strategies for novel candidate molecules.
• Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest.
• Lead the regulatory toxicology strategy, designing and conducting experiments to inform the potential translatability and relevance of nonclinical safety findings to humans in accordance with ICH guidelines.
• Manage nonclinical studies for pre-candidate through late development programs internally and at contract research organizations.
• Closely partner with Research, Clinical Pharmacology, and Biomarkers in the design and interpretation of nonclinical pharmacology, efficacy, and toxicity studies as they relate to the assessment of PKPD and human dose projection.
• Lead program nonclinical scientific subteam to drive IND-enabling activities through BLA filings.
• Partner with Regulatory Affairs and Clinical Development to support key milestones from candidate selection through marketing authorization.
• Responsible for drafting and reviewing nonclinical sections of regulatory documents (IND, IMPD, CTA, IB, briefing packages), including nonclinical pharmacology and toxicology.
• Ability to participate and present at health authority meetings.
• Ability to convey data and strategies clearly and concisely in slides, presentations and oral presentations (internal and external).

What We Seek

• 10+ years of experience in the biotech/pharmaceutical industry in the area of nonclinical drug discovery and development.
• PhD degree (or MS with additional experience) in toxicology, pathology, pharmacology, or related discipline
• Post-doctoral experience preferred.
• DABT certification preferred.
• Experience with RNAi therapeutics, monoclonal antibody therapeutics, and conjugated molecule therapeutics preferred.
• Experience with investigational toxicology and secondary off-target pharmacology screening is preferred.
• Experience with conduct of ICH-compliant regulatory toxicity studies to support late-stage clinical development, label negotiations and BLA filing preferred.
• Previous experience in cardiovascular physiology/pharmacology preferred.
• Excellent interpersonal skills, ability to work in a matrix environment, and develop relationships with key stakeholders.
• Excellent communication and presentation skills to efficiently relay information to project teams, senior management teams, and other key stakeholders.
• Proven ability to be responsible for multiple programs at various stages of drug development.
• Proven ability to work independently and be self-motivated.

• The base salary range for this role is $162,000 - $196,000. The final compensation will be commensurate with relevant experience, skillset, internal equity, and market factors.
• Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, RSUs, and a 401(k) with an employer match. In addition, the comprehensive wellness program includes medical, dental, vision, and LTD coverage and four weeks of time off.
• A commitment to learning and development, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901