Senior Medical Director

2 weeks ago

England, United Kingdom BioTalent Full time

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.

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