Executive Director, Pharmacology

Summary
The Executive Director of Pharmacology will lead the design, execution, and evaluation of pharmacology studies supporting endocrine and orphan lung disease portfolios. This role spans nonclinical through clinical development and may include post-marketing studies. The ideal candidate will bring deep expertise in therapeutic testing modalities, particularly in inhalation and pulmonary therapeutics, and demonstrate proficiency in biomarkers, dosing strategies, PK/PD modeling, and clinical study design. Strategic thinking and hands-on execution are both essential.

Key responsibilities include scientific leadership, vendor oversight, cross-functional collaboration, and driving in vivo and in vitro strategy across the pipeline.

Responsibilities

• Serve as the pharmacology/toxicology lead on drug development teams across pulmonary and endocrine indications.
• Identify and implement preclinical models that reflect patient pathology; develop assays for in vitro and in vivo efficacy or biomarker activity.
• Lead in vivo preclinical safety, PK/PD, and efficacy studies.
• Oversee Pharmacology/PK/PD activities across multiple projects; align scientific approaches with organizational objectives.
• Collaborate with clinical and regulatory teams to design studies with robust pharmacological rationale.
• Define dosage and dosing regimens based on preclinical data; coordinate with CMC and device teams to ensure delivery feasibility.
• Act as scientific liaison with CROs and external partners to execute and manage studies.
• Develop and communicate clinical pharmacology strategies in internal and external forums, including regulatory meetings.
• Address technical and scientific challenges with innovative solutions.
• Contribute to IND strategy and documentation, including pharmacology sections for regulatory submissions.
• Translate complex scientific findings into actionable insights for cross-functional teams.
• Present data to internal leadership and external stakeholders, including at conferences and regulatory/advisory board meetings.
• Maintain scientific and technical expertise through ongoing engagement with literature and industry developments.
• Promote a collaborative, team-oriented culture.

Qualifications

• Ph.D. in Pharmacology, Pharmacokinetics, Biology, or a related field.
• Minimum of 15 years of industry experience in pharmacology or translational sciences, with emphasis on endocrine, pulmonary, or orphan indications.
• Experience with Nintedanib or other antifibrotic agents is highly desirable.
• Strong background in PK/PD modeling, dose selection, and biomarker integration into clinical trials.
• Prior involvement in IND and NDA filings; experience interacting with regulatory authorities on pharmacology topics.
• Proven leadership in cross-functional teams, mentoring junior scientists, and managing external partnerships.
• Excellent communication skills, with the ability to present complex data to both technical and non-technical audiences.
• Experience in fast-paced biotech environments with a balance of strategic and operational capabilities.