Director, Toxicology, Non-clinical Development
Director, Toxicology, Non-clinical Development
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Job Description
Description
Job Title:
Director Toxicology Nonclinical Development
Location:
San Diego CA
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Development Sciences
Strive to Bring a Profound Difference to our Patients
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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 peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visitand engage with us onLinkedInandTwitter.
The Opportunity
Avidity is seeking an experienced nonclinical development scientist to lead a team of toxicologists that spans research and development. In this role the successful candidate will work crossfunctionally in a matrixed environment to define and implement nonclinical development strategies and successfully execute plans for programs from discovery to latestage development. This will be a highly visible role requiring effective interaction with the Head of Toxicology the Research Leadership Team and leaders in Clinical Development among others. The Director will manage a team of toxicologists and mentor support and contribute to their development and growth.
The Director will bring early and latestage drug development experience across multiple therapeutic areas and will be relied upon as an inhouse subject matter expert (SME) in regulatory toxicology strategy dossier writing and health authority interactions. The successful candidate will serve as a mentor and advisor to their team and will consult on all latestage development toxicology plans across therapeutic areas. Responsibilities will include reviewing and designing nonclinical safety studies to support clinical development and interpreting/synthesizing data appropriately. The Director will be responsible for reviewing editing and/or authoring all regulatory submissions and participating in health authority interactions.
The successful candidate will also be expected to serve as a toxicologist on specific research and program teams. In this capacity they will design execute and interpret nonclinical safety studies conducted in multiple species via collaborative partnerships with partner line program representatives (e.g. PKPD bioanalytical biomarkers etc.) and will be heavily involved in regulatory submission writing. The successful candidate must have a demonstrated ability to multitask and function effectively in a fastpaced environment influence decisionmaking around scientific strategy at all levels of the company conduct work independently and enlist the expertise of subject matter experts when necessary to advance the conversation. In this role it will be critical to demonstrate and ensure scientific rigor internally. The ability to comprehend and articulate complex biology to a broad audience internally and externally is essential as there will be opportunities to publish manuscripts and posters present at scientific conferences/forums and engage with consultants and advisors in the field as well as the scientific community at large.
What You Will Contribute
- Serve as a key member of multidisciplinary research and development teams representing the toxicology function to define and implement nonclinical safety evaluation strategy for novel candidate molecules.
- Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest from early development (screening toxicity) through filing (Repro Carcinogenicity etc.).
- Lead the design and conduct of experiments to inform the potential translatability and relevance of nonclinical safety findings to humans.
- Manage nonclinical development studies inhouse and at contract research organizations.
- Closely partner and interact crossfunctionally with Aviditys Biology Biomarkers and PKPD leaders in the design and interpretation of nonclinical pharmacology and efficacy studies related to the assessment of PKPD and human dose projection.
- Draft and review nonclinical sections of regulatory documents (IND IMPD CTA & IB briefing packages) including nonclinical pharmacology pharmacokinetics and toxicology.
- Participate in and lead nonclinical strategy discussions in meetings with various health authorities (FDA EMA PMDA etc.) from preIND through preBLA.
- Represent Avidity with external vendors to manage budgets timelines monitoring protocol design reporting and compliance.
- Mentor and have matrix management responsibilities for other toxicology program representatives by providing scientific guidance and by leading by example.
- Manage a team of toxicologists.
What We Seek
- Minimum of 10 years of relevant experience in toxicology pathology pharmacology or a related discipline with either a PhD or MS; postdoctoral experience preferred. Candidates with an MS typically bring 15 years of experience.
- Excellent interpersonal skills ability to work in a matrix environment and develop relationships with key stakeholders
- Excellent communication and presentation skills to efficiently inform project teams senior management team and other key stakeholders
- Experience with large molecules (monoclonal antibody) and/or oligonucleotide based therapeutic modalities in drug discovery and development desired
- Experience as a company representative on outsourced toxicology studies managing CRO selection contracting budgeting evaluation timelines communication monitoring protocol design study execution reporting and regulatory compliance
- Experience working in a regulated environment and knowledge of GLP regulations and relevant FDA EMA and ICH guidelines
- Experience with latestage development regulatory tox strategy
- Proven ability to work independently and be selfmotivated
What We Will Provide You:
- The base salary range for this role is $228000 $252000. The final compensation will be commensurate with factors such as relevant experience skill set 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
Required Experience:
Director
Employment Type
Full-Time
