Clinical Development Director

An opportunity to lead clinical development for an innovative biopharmaceutical company focused on oncology. This role will oversee clinical development strategy and execution, working closely with cross-functional teams and external partners to advance clinical programs toward regulatory approval and commercialization.

Requirements

Lead clinical development strategy and execution for oncology programs across different stages of development. Oversee clinical trial planning, study design, protocol development, and trial execution. Drive clinical development plans in alignment with regulatory requirements and business objectives. Lead interactions with Japanese regulatory authorities, including PMDA, and support regulatory submissions and approval activities.

Collaborate with global teams, CROs, external partners, and key opinion leaders to ensure successful clinical program delivery. Work cross-functionally with Regulatory Affairs, CMC, Medical Affairs, and Pharmacovigilance teams throughout the product development lifecycle. Evaluate clinical data and provide strategic recommendations to support development decisions and pipeline progression.

Provide clinical development leadership and contribute to the advancement of oncology therapies toward commercialization. Ideal Background Extensive clinical development experience within the pharmaceutical or biotechnology industry, with a strong focus on oncology. Proven experience leading clinical development programs and clinical trials, preferably including late-stage development and Phase III studies.

Experience in clinical development strategy, study design, and execution. Experience with PMDA consultations, regulatory submissions, and drug approval processes in Japan. Experience collaborating with global clinical development teams and external development partners. Strong leadership, strategic planning, and cross-functional stakeholder management skills.

Japanese and English communication skills to support domestic and global collaboration.

Benefits

Why Join? Lead clinical development strategy in the oncology field. Play a key role in advancing innovative therapies toward regulatory approval and commercialization. Collaborate with global teams and external partners. Take on a strategic leadership role with opportunities to influence clinical development and pipeline growth.