Note: The job is a remote job and is open to candidates in USA. Hlx Life Sciences is representing an established rare disease biotech with a commercial and late-stage presence that is expanding and diversifying its pipeline. The Vice President of Clinical Development will lead clinical strategy and development across rare disease programs while contributing to portfolio planning, external asset evaluation, licensing, partnerships and the growth of the clinical development organization.
Responsibilities
- Provide senior clinical and drug development leadership across rare disease programs
- Develop and execute clinical development strategies from early development through late-stage development and registration
- Provide strategic input into overall portfolio planning and prioritisation
- Partner closely with Business Development and senior leadership when evaluating external assets, licensing opportunities and potential new indications
- Assess clinical development opportunities, including development pathways, differentiation, patient populations, endpoints and overall probability of success
- Lead and mentor clinical development colleagues as the organisation and portfolio continue to grow
- Work cross-functionally across Clinical Operations, Regulatory, Biometrics, Translational Medicine, Medical Affairs and Commercial
- Build strong relationships with investigators, KOLs, patient communities and external development partners
- Provide senior-level clinical input into interactions with global regulatory authorities
- Help establish the clinical development infrastructure and leadership required to support a growing rare disease portfolio
Skills
- Significant clinical drug development experience within rare disease
- Experience at VP level, or senior clinical development leaders ready to take on broader organisational responsibility
- Demonstrated leadership of clinical programs across multiple stages of development
- Strong understanding of the complete drug development lifecycle
- Experience contributing to portfolio strategy, indication expansion, external innovation, licensing or business development evaluations would be highly valuable
- A track record of operating effectively within biotech environments where individuals need to work strategically as well as hands-on
- Experience building, developing or leading clinical development teams
- Strong cross-functional leadership and executive-level communication skills
- Nephrology experience is advantageous but is not essential
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