Senior Medical Therapeutic Area Head
2 days ago
About This Opportunity
BioTalent is seeking a highly experienced Senior Medical Director to lead the clinical development of our gene therapy programs.
Mission
We aim to harness the power of advanced genetic science to create transformative therapies that improve and extend lives worldwide.
Job Summary
The Senior Medical Director will oversee the design, execution, and regulatory submissions of our gene therapy programs, requiring expertise in gene therapy, rare diseases, or related fields, and a strong commitment to improving patient outcomes.
Key Responsibilities
Leadership
- Develop and execute clinical development strategies for gene therapy programs from early-phase trials through regulatory approval.
- Serve as a medical 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 Trials
- 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 Submissions
- 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.
Team Management
- 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.
Compensation & Benefits
$250,000 - $320,000 per year, depending on experience, plus comprehensive benefits package, including health insurance, 401(k) matching, and paid time off.
What We Offer
- 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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