Manager ds. badań klinicznych

5 days 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.

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.

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.

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.

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.

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.

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.


Expertise in gene therapy, rare diseases, or related therapeutic areas.
Strong knowledge of clinical trial design, data analysis, and safety monitoring.
Be at the forefront of gene therapy innovation.
Contribute to developing life-changing therapies for patients with unmet needs.



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