Sr. Manager, Clinical Development

Position: Clinical Development Senior Manager Education: see below

Department/Section: Clinical Development

Report to: Head of Clinical Development

Manager for: N/A

Purpose of the job: Lead and drive the overall clinical development process in Japan, including development strategy planning and clinical trial execution, in close collaboration with Japan Drug Development, Global Clinical Focus Teams, and other key stakeholders at headquarters and locally. The role is expected to foster strong cross-functional collaboration, shared accountability, and operational excellence to accelerate patient access to innovative treatments.

Responsibilities:

• Develop and execute robust clinical development strategies aligned with global objectives and local regulatory requirements.
• Deliver high-quality clinical trial data through innovative, efficient, and standardized operational processes.
• Lead Japan clinical development activities in partnership with local and global cross-functional teams, while providing strong scientific and strategic input.
• Build productive relationships with PMDA to achieve alignment on Clinical Development Plans (CDP), clinical trial designs, submission strategies, and approval pathways in collaboration with Regulatory Affairs.
• Oversee and manage CROs to ensure timely trial execution and high-quality deliverables.

Tasks:

• Develop and optimize Japan-specific clinical development strategies in alignment with global development plans through close collaboration with headquarters.
• Contribute to alignment of Japanese CDPs with PMDA and local Key External Experts (KOLs).
• Serve as the local clinical representative in PMDA consultations.
• Support preparation and review of J-NDA CTD documentation.
• Contribute to the successful execution of clinical trials, including feasibility, site selection, patient recruitment, and site engagement, through effective CRO oversight.
• Establish and maintain strong relationships with investigators, academic experts, and other external stakeholders.
• Foster a collaborative and positive working environment and maintain strong partnerships across Lundbeck.

Education / Certifications:

• Bachelor’s degree (scientific background) required, and advanced degree preferred
• Medical Doctor with experience in Neurology or Pharmacist is preferable

Experiences:

• Minimum 10 years of experience in clinical development within the pharmaceutical industry and/or CRO environment. (Experience within a pharmaceutical company is preferred.)
• Demonstrated experience in developing Clinical Development Plans (CDPs).
• Experience in neurological disease development, including neurodegenerative diseases, neuroimmunology, or migraine.
• Hands-on experience interacting with PMDA/MHLW.
• Experience managing global and/or Asian clinical trials.
• Proven ability to work effectively within global cross-functional teams.
• Preferably, prior people management experience, team leadership responsibilities, or a strong aspiration to further develop leadership capabilities toward future management roles.

Competencies:

• English skill (verbal and written)
• Japanese skill (verbal and written)
• Demonstrates Lundbeck values of Curiosity, Adaptability, and Accountability.
• Excellent communication and presentation skills in both Japanese and English.
• Foster strong cross-functional collaboration and shared accountability across local and global teams to successfully deliver clinical development objectives and accelerate patient access to innovative treatments.
• Demonstrate flexibility in navigating evolving clinical landscapes, operational challenges, and changing business priorities while adapting development strategies to local and global needs.
• Maintain a results-oriented mindset by ensuring high-quality and timely execution of clinical development activities, while balancing scientific rigor & latest scientific evolvements in the field, patient safety and operational excellence.
• Uphold the highest ethical standards, transparency, and compliance in all clinical development activities and interactions. Foster a psychologically safe environment that encourages open communication, diverse perspectives, and continuous learning.
• Solid understanding of GCP/ICH guidelines and applicable clinical trial regulations.