Position Summary
The Associate Director – Clinical Development plays a pivotal role in shaping and executing clinical development strategies. This individual will be responsible for the design, implementation, and interpretation of clinical trials, working collaboratively with cross-functional teams to advance the development pipeline. The ideal candidate brings a strong foundation in clinical research and drug development, with the ability to translate scientific insights into actionable clinical strategies.
Key Responsibilities
* Design and oversee clinical development programs aligned with regulatory and business goals.
* Contribute to the development of clinical protocols, study reports, investigator brochures, and other essential clinical documents.
* Collaborate with cross-functional teams including biostatistics, regulatory affairs, medical affairs, and clinical operations to ensure seamless trial execution.
* Analyze and interpret clinical trial data to support decision-making and regulatory submissions.
* Monitor scientific and competitive developments in relevant therapeutic areas to inform clinical strategy.
* Provide scientific input for interactions with investigators, regulatory authorities, and key opinion leaders.
* Support the preparation of regulatory submissions including INDs, NDAs, and clinical sections of global filings.
Qualifications
Education:
* Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
* Advanced degree (MD or equivalent)
Experience:
* Minimum of 1–2 years in clinical research or clinical development within the pharmaceutical, biotechnology, or CRO industry.
* Fluent in English;
proficiency in Italian is a plus.
* Proficient with productivity and collaboration tools (e.G., Google Workspace, Microsoft Office).
* Solid understanding of medical terminology and clinical trial methodologies.
* Familiarity with regulatory frameworks and statistical principles in clinical research.
* Strong scientific writing skills, including experience drafting clinical protocols and regulatory documents.
* Ability to interpret complex clinical data and communicate findings effectively to diverse stakeholders.
* Excellent interpersonal and collaboration skills in a cross-functional environment.
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