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    Associate Director Regulatory Affairs CMC (FSP)At PPD Latin America, we're committed to empowering our customers to make a positive impact on a global scale. As a key member of our team, you'll have the opportunity to contribute to the development and execution of CMC regulatory strategies for biological products in the EMEA region.We're seeking an...

Director Clinical Development

Il y a 2 mois


Occitanie, France Pact & Partners International Temps plein

About the Company:

Our client focuses on improving access to quality healthcare. The Clinical Development Director will lead the development of innovative therapies, particularly cellular therapies for rare diseases and oncology. This role oversees the entire clinical process from early-stage research to clinical trials and regulatory approval. The CDD will collaborate with internal teams and external stakeholders to ensure project success.


Responsibilities:

Strategic Leadership: Develop and execute clinical strategies for cellular therapy projects, aligned with corporate goals.

Clinical Trial Oversight: Manage phase II and III trials, including design, implementation, and analysis.

Regulatory Strategy: Partner with regulatory affairs to prepare global regulatory submissions.

Scientific Expertise: Serve as a key advisor for the evaluation and advancement of research projects.

Stakeholder Engagement: Collaborate with academic experts, investigators, and patient advocacy groups.

Cross-Functional Collaboration: Work with preclinical research, medical affairs, marketing, and operations teams.


Required Competencies:

Education: MD or equivalent, ideally in Oncology, or related fields. A PhD or clinical research qualifications are a plus.

Experience: Minimum of 10 years in clinical research, with leadership in cellular therapies.

Strategic Thinking: Strong analytical and planning skills.

Leadership: Proven ability to build and lead teams.

Communication Skills: Excellent English proficiency.

Regulatory Knowledge: Deep understanding of global regulatory requirements.

Compensation:

Competitive salary and benefits based on experience.