ASSOCIATE DIRECTOR MWL-104

Planet Pharma


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. Technical Skills & Competencies - 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. #J-18808-Ljbffr

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