The Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP) development, due diligence projects, and clinical-regulatory compliance.

Essential Duties and Responsibilities

Clinical Development:

• Design and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to develop study protocols, analyze trial data, and manage trial progress.

Medical Monitoring:

• Provide medical oversight during clinical trials to ensure participant safety and data integrity.
• Review and interpret safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams.

Target Product Profile (TPP) Contributions:

• Develop and refine TPPs by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.
• Align TPPs with regulatory requirements and commercial goals to guide product development strategies.

Due Diligence Projects:

• Conduct evaluations of potential new products or acquisitions by assessing their clinical viability, market potential, probability of clinical and regulatory success etc.
• Provide expert recommendations based on scientific and medical analysis.

Regulatory Compliance:

• Ensure adherence to FDA guidelines for 505(b)(2) applications and other regulatory standards.
• Addressing medical/clinical queries from health authorities.

Leadership and Collaboration:

• Lead cross-functional teams in clinical development, medical affairs, and strategic planning.
• Foster collaboration among stakeholders to achieve project milestones efficiently.

Education and Experience

• 5 to 10 years in respiratory disease clinical trials with a strong background in clinical development. Familiarity with respiratory endpoints such as pulmonary function tests (PFTs) and biomarkers is essential.
• MD or equivalent degree with a focus on respiratory medicine or fellowship in a related field.
• Proven leadership abilities, strong knowledge of regulatory frameworks (e.g., FDA), GCP guidelines, and quality management systems.
• Preferred but Not Mandatory: Medical practice experience in respiratory medicine.

Lupin  is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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