Position Overview : The SVP of Clinical Development will play a critical role in leading our clinical development efforts from early-stage research through to late-stage clinical trials and regulatory submissions.
This individual will be responsible for developing and executing the clinical strategy, ensuring the successful design and implementation of clinical programs, and fostering collaborations across internal and external stakeholders.
As a key member of the executive team, you will provide strategic leadership and scientific guidance to advance our clinical assets and support our mission of delivering transformative therapies to patients.
Key Responsibilities :
- Lead the design and execution of clinical development plans across all phases of development.
- Oversee the conduct of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
- Provide strategic direction and guidance on regulatory submissions, including INDs, CTAs, NDAs, and BLAs.
- Collaborate with cross-functional teams, including preclinical, regulatory, CMC, and commercial, to ensure alignment on clinical strategy and objectives.
- Engage with key opinion leaders, clinical investigators, and regulatory authorities to drive program success.
- Manage and mentor a high-performing clinical development team, fostering a culture of innovation, collaboration, and excellence.
- Represent the company at scientific and medical meetings, investor presentations, and regulatory interactions.
- Monitor and assess emerging clinical data, making informed decisions to adjust strategies as needed.
Qualifications :
- MD, PhD, or equivalent advanced degree in a relevant scientific discipline.
- Minimum of 15 years of experience in clinical development, with a proven track record in successfully leading programs from early development through to regulatory approval.
- Deep expertise in oncology, immunology, and rare diseases.
- Strong knowledge of global regulatory requirements and clinical trial design.
- Demonstrated ability to lead and inspire cross-functional teams in a fast-paced, entrepreneurial environment.
- Excellent communication and leadership skills, with the ability to influence at all levels of the organization.
- Strategic thinker with a hands-on approach and a passion for innovation.
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