Director Clinical Development

60571 - Senior Director Clinical Development

The opportunity:

The Senior Director of Clinical Development is responsible for strategic leadership, execution, and oversight of global clinical development programs across all phases of clinical research. This role requires a seasoned professional capable of managing complex clinical programs and leading multidisciplinary teams in a highly matrixed environment. The Senior Director will provide visionary guidance to study teams, ensuring the alignment of clinical strategies with overall program objectives. The individual is expected to demonstrate extensive experience in the end-to-end management of clinical research projects, including the preparation, review, and approval of key documents such as protocols, Investigator’s Brochures, clinical study reports, and regulatory submission materials. This role is critical in designing and implementing clinical development plans, leading asset strategies, and driving collaboration with key internal stakeholders across functions such as commercial, regulatory, pharmacovigilance, manufacturing, and pre-clinical development. The Senior Director will serve as a clinical leader for INDs, NDAs, BLAs, and other global regulatory filings, while also cultivating relationships with thought leaders and stakeholders in assigned therapeutic areas.

How you’ll spend your day:

• Serve as a senior leader within the organization and a core member of the Global Program Team, driving strategic clinical development initiatives.
• Develop, oversee, and manage multiple Clinical Development Plans with a focus on long-term program success and alignment with corporate goals.
• Lead cross-functional clinical development expert teams, ensuring optimal integration of efforts across all departments.
• Provide clinical leadership and oversight for study design, initiation, resource planning, implementation, and completion of global clinical trials.
• Represent clinical development in high-level internal and external meetings, including Investigator Meetings, advisory boards, and regulatory authority discussions.
• Lead interactions with global regulatory authorities, providing clinical expertise and strategic direction to facilitate successful submissions.
• Drive matrix collaboration with functional areas such as medical affairs, health economics, regulatory, commercial, and supply chain teams to ensure cohesive program execution.
• Oversee the preparation and review of clinical documents, including Protocols, Clinical Study Reports, Investigator’s Brochures, and global regulatory filings.
• Foster and maintain strategic partnerships with key opinion leaders, external collaborators, and academic institutions to advance clinical development objectives.
• Serve as medical monitor, providing high-level medical oversight, including study design, data analysis, patient safety, and CRO engagement.
• Proactively identify and mitigate risks across clinical programs, ensuring quality and compliance with all regulatory requirements.
• Mentor and develop clinical development team members, promoting a culture of excellence, innovation, and accountability.

Your experience and qualifications:

Education Required

• MD with board certification in psychiatry (preferred) or other relevant specialties.
• Advanced training or specialization in clinical research, drug development, or related fields is highly desirable.

Experience Required

• A minimum of 3 years of pharmaceutical/biotechnology industry experience in clinical development, with a proven track record of leading programs through all stages of development, including regulatory approvals.
• Extensive experience managing and mentoring cross-functional teams in a matrix environment, with demonstrated ability to drive alignment and deliver results.
• Expertise in psychiatry or a related therapeutic area, with deep knowledge of disease-specific clinical and regulatory landscapes.
• Strong strategic thinking and decision-making skills, with the ability to balance short-term needs with long-term goals.
• Experience in global clinical trials, regulatory interactions, and dossier preparation for INDs, NDAs, and BLAs.
• Advanced understanding of clinical trial design, data analysis, and risk management practices.

Skills Required

• Exceptional interpersonal, leadership, and communication skills with the ability to influence across all organizational levels.
• Strong analytical capabilities and problem-solving skills to address complex clinical development challenges.
• High proficiency in managing multiple, simultaneous projects with aggressive timelines in a dynamic environment.
• Fluent in English, with superior oral and written presentation skills for internal and external audiences.