The Associate Director, Nonclinical Development will serve as a key scientific contributor within ... Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise ...
The Associate Director, Nonclinical Development will serve as a key scientific contributor within ... Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise ...
The VP will play a critical role in shaping the future direction and growth of our Clinical ... You will have direct accountability for client relationships, business development, delivery ...
The VP will play a critical role in shaping the future direction and growth of our Clinical ... You will have direct accountability for client relationships, business development, delivery ...
Position Overview The Associate Director, Nonclinical Development will serve as a key scientific ... Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise ...
Position Overview The Associate Director, Nonclinical Development will serve as a key scientific ... Reporting to the VP, Translational Sciences, the role requires strong pharmacology expertise ...
Collaborate with Clinical Development and Clinical Pharmacology to ensure nonclinical findings ... direct engagement with regulators * Oversee the selection and management of CROs, ensuring ...
Collaborate with Clinical Development and Clinical Pharmacology to ensure nonclinical findings ... direct engagement with regulators * Oversee the selection and management of CROs, ensuring ...
The VP will play a critical role in shaping the future direction and growth of our Clinical ... You will have direct accountability for client relationships, business development, delivery ...
The VP will play a critical role in shaping the future direction and growth of our Clinical ... You will have direct accountability for client relationships, business development, delivery ...
Reporting to the Chief Medical Officer, the SVP of Clinical Development, FcRn/immunology will serve ... Non-clinical teams, Competitive Intelligence teams, Medical Affairs and Business Development
Reporting to the Chief Medical Officer, the SVP of Clinical Development, FcRn/immunology will serve ... Non-clinical teams, Competitive Intelligence teams, Medical Affairs and Business Development
... nonclinical safety plansalignwith the company's development priorities and risk tolerance ... Direct the design and execution of preclinical pharmacology, pharmacokinetic, mammalian toxicology ...
... nonclinical safety plansalignwith the company's development priorities and risk tolerance ... Direct the design and execution of preclinical pharmacology, pharmacokinetic, mammalian toxicology ...
... 10+(VP) years of clinical development experience within a biotech/pharmaceutical setting with a ... non-monetary) program reflects the value each person brings. The expected salary range for this ...
... 10+(VP) years of clinical development experience within a biotech/pharmaceutical setting with a ... non-monetary) program reflects the value each person brings. The expected salary range for this ...
Vice President, Clinical Development
OR · On-site +1
The Vice President, Clinical Development (Immunology & Inflammation), reporting to the SVP of IBD Clinical Development, will provide strategic and operational leadership across Spyre's clinical ...
Vice President, Clinical Development
OR · On-site +1
The Vice President, Clinical Development (Immunology & Inflammation), reporting to the SVP of IBD Clinical Development, will provide strategic and operational leadership across Spyre's clinical ...
The Opportunity The Senior Vice President (SVP) of Clinical Development will provide strategic ... Lead and mentor a multidisciplinary team of medical directors, pharmacologists, and clinical ...
The Opportunity The Senior Vice President (SVP) of Clinical Development will provide strategic ... Lead and mentor a multidisciplinary team of medical directors, pharmacologists, and clinical ...
Vice President (VP), Clinical Development - Infectious Disease. Reports to the Chief Medical ... Senior Director level or above experience. * Board certification in Infectious Disease (plus)
Vice President (VP), Clinical Development - Infectious Disease. Reports to the Chief Medical ... Senior Director level or above experience. * Board certification in Infectious Disease (plus)
The VP, Clinical Development will be a primary point person for medical oversight of clinical ... Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data ...
The VP, Clinical Development will be a primary point person for medical oversight of clinical ... Direct and mentor a team of medical monitors, ensuring high standards of medical oversight and data ...
South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs) The VP, Clinical Development, working closely with the Global Program Head (GPH), will have direct responsibility as ...
South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs) The VP, Clinical Development, working closely with the Global Program Head (GPH), will have direct responsibility as ...
Position Summary Reporting to the VP, Non Clinical Development, the Director, DMPK will lead the company's DMPK and translational pharmacology function, collaborating across disciplines to optimize ...
Position Summary Reporting to the VP, Non Clinical Development, the Director, DMPK will lead the company's DMPK and translational pharmacology function, collaborating across disciplines to optimize ...
... direct accountability for IND-enabling programs. * Deep expertise in at least two of the three core ... Track record of successful IND submissions with clear accountability for the nonclinical ...
... direct accountability for IND-enabling programs. * Deep expertise in at least two of the three core ... Track record of successful IND submissions with clear accountability for the nonclinical ...
The VP, Clinical Development will have direct responsibility as Clinical Lead accountable for clinical development strategy and execution across one or more programs. The successful candidate will be ...
The VP, Clinical Development will have direct responsibility as Clinical Lead accountable for clinical development strategy and execution across one or more programs. The successful candidate will be ...
Opportunity Overview We are seeking an experienced Director of Nonclinical Development to provide scientific leadership and hands‑on execution of nonclinical strategies across our pipeline. This ...
Quick apply
Opportunity Overview We are seeking an experienced Director of Nonclinical Development to provide scientific leadership and hands‑on execution of nonclinical strategies across our pipeline. This ...
Vice President, Clinical Development (Gastroenterology) Full Time Malvern, PA, US Uniquity Bio is a ... directors. Qualifications Required * M.D. or equivalent medical degree from an accredited ...
Vice President, Clinical Development (Gastroenterology) Full Time Malvern, PA, US Uniquity Bio is a ... directors. Qualifications Required * M.D. or equivalent medical degree from an accredited ...
Regulatory Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The Associate ... Regulatory Strategy Development * Develop and implement global regulatory strategies for gene ...
Quick apply
Regulatory Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The Associate ... Regulatory Strategy Development * Develop and implement global regulatory strategies for gene ...
The Position The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs in Organon's portfolio of products across Women's Health ...
The Position The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs in Organon's portfolio of products across Women's Health ...
Director Vp Non Clinical Development information
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Associate Director, Nonclinical Development
Boston, MA • On-site
Full-time
Posted 11 days ago
Key responsibilities
Evaluate mechanism of action, target engagement, exposure-response relationships, and dose selection strategies across development programs.
Design and oversee translational research strategies connecting nonclinical findings to clinical hypotheses.
Lead the planning, oversight, and interpretation of nonclinical studies conducted internally and through CRO partners.
Job description
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn's AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn's AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
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, 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.
Proposed pay range
$179,000-$202,000 USD
About Avalyn Pharma
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1 - 10 Employees
Headquarters location
Seattle, WA, US
Year founded
2011