About the Company

Our client is a cutting-edge biotechnology company focused on developing innovative gene therapy treatments to address unmet inherited medical disorders . Our mission is to harness the power of advanced genetic science to create transformative therapies that improve and extend the lives of patients worldwide. We foster a collaborative and dynamic environment where scientific excellence, creativity, and passion thrive.

Position Summary

The Senior Medical Director will play a pivotal role in leading the strategic and operational aspects of clinical development for our gene therapy programs. This individual will oversee the design and execution of clinical trials, collaborate cross-functionally to advance our pipeline, and ensure the delivery of high-quality, patient-centric therapeutic solutions.

This is a high-impact leadership role that requires a visionary approach to developing novel therapies, deep expertise in gene therapy or related fields, and a strong commitment to improving patient outcomes.

Key Responsibilities

Strategic Leadership

• Develop and execute clinical development strategies for gene therapy programs, from early-phase trials through regulatory approval.
• Serve as a medical and scientific expert, providing guidance on program direction and ensuring alignment with corporate objectives.
• Collaborate with R&D, regulatory, commercial, and other stakeholders to shape the product development roadmap.

Clinical Development Oversight

• Design, oversee, and interpret clinical trials, ensuring adherence to regulatory requirements and Good Clinical Practice (GCP).
• Provide medical oversight and support for all clinical programs, including protocol development, patient eligibility, safety monitoring, and data analysis.
• Lead interactions with external advisors, investigators, and clinical research organizations (CROs).

Regulatory engagement

• Partner with regulatory teams to develop strategies for regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and Biologics License Applications (BLAs).
• Represent the company in meetings with regulatory agencies, providing medical and scientific insights to support submissions.

Stakeholder Collaboration

• Partner with external stakeholders, including key opinion leaders (KOLs), patient advocacy groups, and academic collaborators, to ensure clinical programs align with patient and market needs.
• Serve as a key spokesperson for the company at scientific conferences, advisory boards, and investor meetings.

Team Leadership

• Mentor and develop clinical and medical affairs team members, fostering a culture of scientific rigor and innovation.
• Contribute to the recruitment and retention of top talent in clinical development.

Qualifications

Education and Experience

• MD or equivalent medical degree, with clinical experience with inherited genetic disorders
• 3 - 5 years of experience in clinical development within the biotechnology or pharmaceutical industry, including leadership roles.
• Proven track record of successfully advancing gene therapy, cell therapy, or biologics programs through clinical development.
• Experience in regulatory interactions and submissions for novel therapeutic programs.

Skills and Competencies

• Expertise in gene therapy, rare diseases, or related therapeutic areas.
• Strong knowledge of clinical trial design, data analysis, and safety monitoring.
• Exceptional communication and interpersonal skills, with the ability to engage effectively across diverse audiences.
• Strategic thinker with the ability to prioritize and make decisions in a fast-paced, high-growth environment.
• Leadership skills to inspire and manage cross-functional teams and external collaborations.

Why Join Us?

• Innovative Science: Be at the forefront of gene therapy innovation.
• Impactful Mission: Contribute to developing life-changing therapies for patients with unmet needs.
• Collaborative Culture: Work with a passionate and driven team of professionals.