Associate Director, Non Clinical Development

Avalyn Pharma; Boston (MA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

401k with company match

Flexible schedules

Remote work options

Medical, dental, vision coverage

Tuition reimbursement

Job summary

Avalyn Pharma in the Boston area seeks an Associate Director, Nonclinical Development to lead pharmacology and translational science efforts across inhaled programs. You will help shape dose selection strategies, develop translational approaches, and ensure alignment with regulatory expectations.

The role requires extensive nonclinical pharmacology expertise, strong scientific writing skills for IND-related documents, and a collaborative mindset to drive program objectives in a dynamic biotech

Qualifications

• Ph.D. (or equivalent) in Pharmacology, Physiology, Pulmonary Biology, Biochemistry, or related field is required.
• 7–10+ years of translational sciences/nonclinical pharmacology experience in biopharma is required.
• Experience with inhaled drug delivery/respiratory pharmacology is highly preferred.
• Deep knowledge of pulmonary fibrosis biology and related models is required.
• Biomarker strategy experience for early-phase trials is desired.
• Strong scientific writing skills with regulatory submissions experience is essential.
• Excellent communication to distill data for cross-functional audiences.
• Collaborative and fast-paced team player in a small company environment.

Responsibilities

• Apply pharmacology to dose selection strategies across development programs, including inhalation programs.
• Design translational research strategies linking nonclinical findings to clinical hypotheses for inhaled therapies.
• Lead planning and interpretation of nonclinical studies with CRO partners.
• Develop nonclinical/clinical bioanalysis strategies as appropriate.
• Identify translatable biomarkers for early clinical trials.

Skills

Pharmacology expertise

Scientific writing

Cross-functional communication

Team collaboration

Inhalation pharmacology

Education

Ph.D. in Pharmacology or related field

Job description

Position Overview:

The Associate Director, Nonclinical Development will serve as a key scientific contributor within the Translational Sciences organization, supporting the advancement of Avalyn's pipeline through pre-clinical and clinical development stages. This individual will contribute to integrated development strategies that leverage pharmacology, translational science, biomarkers, and nonclinical evidence packages to inform candidate progression, dose selection strategies, regulatory submissions, and clinical development plans. Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise, excellent scientific judgment, and exceptional technical writing skills to effectively synthesize and communicate complex data to cross-functional teams, regulatory agencies, and external stakeholders. The successful candidate will be a highly collaborative partner with a focus on scientific rigor, operational excellence, and advancing program objectives in a dynamic small biotech environment.

Key Responsibilities:

• Apply pharmacology expertise to evaluate mechanism of action, target engagement, exposure-response relationships, and dose selection strategies across development programs, including inhalation programs and respiratory models.
• Design and execute translational research strategies that connect nonclinical findings to clinical hypotheses for inhaled anti-fibrotic therapeutics.
• Lead the planning, oversight, and interpretation of nonclinical studies designed internally and conducted through CRO partners, ensuring alignment with program objectives, timelines, and regulatory expectations.
• Contribute to the development and oversight of nonclinical and clinical bioanalysis strategies and activities, as appropriate.
• Identify and qualify translatable biomarkers that can be deployed in early clinical trials to assess target engagement and disease modification.
• Partner with CMC, Clinical Pharmacology, Regulatory, and Biostatistics to integrate translational data into IND-enabling packages and clinical study design.
• Author, review, and provide strategic input to regulatory documents, including IND submissions, investigator brochures, briefing documents, nonclinical overviews, and clinical development plans, applying strong scientific writing and communication skills.
• Monitor external scientific and competitive landscapes to identify emerging opportunities, technologies, and development strategies relevant to respiratory diseases and broader portfolio objectives.
• Evaluate nonclinical and clinical data to identify opportunities, risks, and key development decisions across the portfolio.
• Present data and strategies at internal team meetings and external scientific conferences.

Qualifications:

• Ph.D. (or equivalent degree) in Pharmacology, Physiology, Pulmonary Biology, Biochemistry, or a closely related field is required.
• A minimum of 7-10 plus years of relevant industry experience in translational sciences, nonclinical pharmacology, or related functions within biopharmaceutical drug development is required.
• Demonstrated experience with inhaled drug delivery and/or respiratory pharmacology is highly preferred.
• Deep knowledge of pulmonary fibrosis biology and relevant in vitro, ex vivo, and in vivo disease models is required; familiarity with complex signaling pathways is a plus.
• Familiarity with biomarker strategy, including identification, qualification, and application in early-phase clinical trials.
• Exceptional scientific writing skills with demonstrated experience serving as a primary author for regulatory submissions, development plans, study reports, investigator brochures, briefing books, and manuscripts.
• Strong scientific communication skills; able to distill complex data for cross-functional audiences.
• Collaborative and team-oriented with the ability to thrive in a fast-paced, small company environment.

WORKING AT AVALYN

We are a vibrant biotech dedicated to making a meaningful impact in the lives of patients with rare lung diseases.

At Avalyn, we are committed to fostering a culture that values collaboration, continuous improvement, and professional growth. We maintain an energetic workplace where open communication, supportive feedback, and a dynamic atmosphere encourage creative thinking and freedom of expression. This results in an empowering environment where our team is inspired to contribute to our mission every day.

Diversity, Equity, and Inclusion at Avalyn

Diversity, inclusion, and equity are vital elements of our culture, and we work hard to ensure all voices are welcomed, heard, and respected.

Our goal is to continue building a diverse and inclusive workforce at all levels. More than 50% of our organization comprises women, including nearly half its leadership and Board of Directors.

Competitive salaries, a rewarding bonus program, and long-term incentive opportunities

401(k) with company match

Enjoy flexible schedules and remote work options that support a healthy work-life balance

Comprehensive medical, dental, and vision coverage, along with short-term and long-term disability, life, and AD&D benefits

Includes vacation days, year-end company closure, holidays and floating holidays, volunteering time, sick and medical leave

Tuition reimbursement, continuing education, conference opportunities, and leadership training