Spur Therapeutics · 4 days ago
Executive Director or VP, Head of Clinical Development
New York, NY
Full-time
Hybrid
Director/Executive
$340K/yr - $410K/yr
10+ years expSpur Therapeutics is a clinical-stage biotech company focused on developing innovative gene therapies. The ED/VP, Head of Clinical Development will provide strategic and technical leadership for clinical stage assets, overseeing clinical development plans and ensuring high-quality execution of major milestones.
Biotechnology
Responsibilities
Lead the creation and execution of strategic clinical development plans within set timelines
Build, lead, and develop a highly productive and collaborative clinical development organization, providing strong strategic and tactical leadership to the team
Lead the statistical strategy for all trials, assessing statistical aspects of clinical studies and submissions
Be accountable for the design, execution, and interpretation of all clinical studies conducted by the company
Ensure that clinical trials are conducted with quality, in compliance with GCP and relevant guidelines, rules and regulations
Provide regulatory strategy based on the foundation of an orphan product in the gene therapy space developed by a small company
Lead the communication of data to regulatory agencies ensuring a strong narrative arc that addresses the unmet needs, attributes of the programs, and meaningfulness of Spur’s goals
Develop and maintain key opinion leader relationships
Present data and progression of development milestones to key internal and external stakeholders, including the Executive Leadership Team and the Board of Directors
Attend and present clinical data at key medical and scientific meetings and to partner with investigators where appropriate
Remain current in ongoing, relevant therapeutic areas and gene therapy programs
Qualification
Required
MD with at least 10 years of experience in clinical trial development, execution, and operations with demonstrated/increasing responsibilities
Experience in late phase clinical development, specifically within the rare disease arena
Experience in dealing with regulatory agencies including FDA and EMA/MHRA
Excellent writing, organizational, and communication skills with strong attention to detail
Experience leading high functioning teams and working closely with external partners, consultants, and contractors
Must be willing and able to be 'hands on' and assist in all aspects of Clinical Development workstreams
Proactively identify risks to timelines and develop contingency plans
Possess a collaborative working style with ability to partner across and outside the organization
Demonstrate accountability and ability to work independently and make decisions/recommendations
Possess strong organizational skills
Ability to prioritize activities and contribute to multiple projects in parallel
Company
Spur Therapeutics
Spur Therapeutics is a clinical-stage biotechnology company focused on developing life-changing gene therapies for debilitating chronic conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
James Davies
Director, Corporate Development and Strategy, Chief of Staff to CEO
Michael Parini
Chief Executive Officer
Recent News
2024-05-12
Company data provided by crunchbase