Study Com Jobs in Raleigh, NC (NOW HIRING)

The Senior Director, Development will report to the Vice President of Operations and dotted line to the Chief Scientific Officer and will play a central role in advancing the company’s portfolio of inhaled and prophylactic immunotherapies for acute respiratory infections. This position is responsible for leading and managing the company’s research and preclinical development programs, guiding a team of scientists and outside vendors and collaborators in executing high-quality science that advances candidates from early discovery through IND filing. The Senior Director will work in close collaboration with the VP Operations and CSO to shape and execute the company’s development strategy and will contribute to the evaluation of new technologies and product opportunities.

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Essential Duties and Responsibilities

• Lead day-to-day execution of the company's preclinical development programs, ensuring studies are conducted with scientific rigor and in alignment with program objectives.
• Manage and mentor a team of research scientists and associates, including hiring, training, coaching, performance appraisal, and professional development.
• Collaborate with the VP Operations and CSO to develop and refine the company’s research and development strategy, including the design and prioritization of studies to advance the drug candidate pipeline.
• Design and oversee in vitro and in vivo studies to characterize therapeutic candidates, including PK, PD, efficacy, and safety assessments.
• Ensure research programs are executed on schedule, within budget, and in compliance with applicable GLP, GMP, and regulatory standards.
• Responsible for creating budgets and tracking spending for lab and development programs.
• Manage relationships with contract research organizations (CROs) and external collaborators, including defining scope of work, overseeing study execution, and reviewing data outputs.
• Contribute to the preparation of research reports, regulatory submissions, grant applications, and scientific publications.
• Support grant management activities by ensuring timely delivery of grant milestones and contributing to new grant and contract applications.
• Evaluate external technologies and scientific literature to identify opportunities to strengthen the company's research capabilities and pipeline.
• Work closely with cross-functional teams including regulatory affairs, project management, and business development to align research and development activities with broader company goals.
• Foster a culture of scientific excellence, collaboration, and open communication within the development team.
• Represent the company's research programs to external partners, collaborators, and investors as appropriate.

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Qualifications/Requirements

• PhD in immunology, virology, pharmacology, bioengineering, or a closely related field required.
• Minimum of 8–12 years of experience in the biotechnology or pharmaceutical industry, with a strong record of accomplishment in research and preclinical drug development.
• Demonstrated expertise in therapeutic antibody research and development, from early discovery through preclinical development stages.
• A strong working knowledge of biologics manufacturing (upstream and downstream) as well as formulation optimization and stability studies is essential.
• Hands-on experience designing and executing in vitro and in vivo pharmacology studies and interpreting complex data sets.
• Experience leading or co-leading cross-functional project teams that have advanced candidates into the clinic.
• Demonstrated success managing CRO relationships and working with collaborators.
• Experience with PK, PD, and ADA assay development and analysis in support of clinical development activities.
• Prior experience in the development of respiratory therapeutics and/or antivirals is strongly preferred.
• Experience working in an early-stage or growth-stage biotech environment is preferred.
• Depth of scientific expertise evidenced by publications, presentations, or patents in the relevant field.
• Proven ability to recruit, develop, and retain scientific talent in a collaborative team environment.
• Good knowledge of GLP, GMP and GCP regulatory requirements
• Excellent written and verbal communication skills with the ability to present complex scientific data clearly and persuasively to both technical and non-technical audiences.

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​How to Apply​​​​

To apply for this position, please send your resume and cover letter to hr@inhalon.com.

Thank you for your interest in Inhalon Biopharma. We are an equal opportunity employer.

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