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Senior Medical Director, Clinical Development
2 months ago
About i-Pharm Consulting:
We are a leading consulting firm dedicated to pioneering advancements in the biopharmaceutical sector, focusing on treating rare and severe diseases. Our mission is to address the unmet medical needs of underserved patient populations through the development of innovative therapies.
Our Pipeline:
Our current pipeline emphasizes therapies for rare metabolic disorders, with leading programs in advanced stages of development. These initiatives are designed to meet the critical needs of both pediatric and adult patients suffering from life-threatening conditions and other rare diseases associated with significant health risks.
Job Summary:
We are seeking an accomplished and driven individual to fill the role of Senior Director of Clinical Development. This role is pivotal in guiding our clinical development efforts, specifically in the area of rare diseases and metabolic disorders. The successful candidate will collaborate closely with multidisciplinary teams, including those in clinical operations, regulatory affairs, and medical affairs, to ensure the effective execution of clinical trials and the progression of our therapeutic candidates.
Key Responsibilities:
- Lead and manage clinical development activities from early to late-stage phases.
- Provide medical and scientific expertise in the planning, implementation, and assessment of clinical studies.
- Act as the medical monitor for ongoing trials, ensuring patient safety and data quality.
- Collaborate with internal teams to create and implement clinical and regulatory strategies.
- Engage with external experts, investigators, and regulatory bodies to support program development.
- Contribute to the preparation of clinical documentation, regulatory filings, and scholarly publications.
- Stay updated on the latest developments in rare and metabolic diseases.
Requirements:
- MD with board certification or completed residency in a relevant specialty.
- Minimum of 5 years of experience in clinical development within the biotech or pharmaceutical industry.
- Preferred experience in rare diseases or metabolic disorders.
- Proven expertise in leading clinical development programs and managing trials.
- Experience in medical monitoring and ensuring patient safety in clinical studies.
- Ideally, experience in pediatric clinical development.
- Strong analytical and decision-making abilities.
- Excellent communication and teamwork skills.
Why i-Pharm Consulting:
A stimulating and supportive environment where your work can significantly impact the lives of patients. A competitive compensation and benefits package, coupled with the opportunity to contribute to innovative and meaningful projects, make this an exciting place to advance your career. Join our mission to develop transformative therapies for rare diseases, bringing new hope to patients and their families worldwide.
