The Neuropsychiatry 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 regulatory compliance. The ideal candidate will have training in neurology or psychiatry and experience working in neurology and psychiatric disease trials.
Responsibilities
Essential Duties and Responsibilities
Clinical Development
Design and execute clinical trials for neuropsychiatric products, ensuring compliance with regulatory requirements.
Collaborate with cross-functional teams to develop study protocols 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 comprehensive evaluations of potential new products or acquisitions by assessing their clinical viability, market potential, probability of clinical/regulatory success etc
Provide expert recommendations based on scientific and medical analysis.
Regulatory Compliance
Ensure adherence to regulatory standards (e.g., FDA) and quality management systems.
Addressing clinical/medical queries from health authorities.
Qualifications
Education and Experience
5 to 10 years in neurology or psychiatry, with a focus on clinical trials and patient care.
MD or equivalent degree with training in neurology or psychiatry.
Proven leadership abilities, strong knowledge of regulatory frameworks, GCP guidelines, and quality management systems.
Medical practice experience in neuropsychiatry.
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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