Vice President, Clinical Operations

Vice President, Clinical Operations About Us

Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.

Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.

Position Summary

The Vice President of Clinical Operations will drive the company’s development strategies by playing a lead role in the implementation of the company’s clinical studies and programs. The position will lead the strategic application and tactical execution including management, planning, and implementation of clinical studies and programs. In this role, the ideal candidate’s guidance and learning throughout the planning and implementation phases will ensure clinical operations timelines are met across the organization. The Vice President of Clinical Operations reports to the CMO and will also help set the direction for the Clinical Operations organization including hiring and mentoring of staff.

Some specific duties and tasks include, but are not limited to, the following:

• Oversee the company’s Clinical Operations activities and implementation of clinical studies and development programs.
• Build and support a team of professionals responsible for the development of clinical operations protocols and the review, interpretation, and communication of strategy, progress, and emerging data of ongoing research projects within and outside the organization.
• Responsible for strategically planning clinical trials, resourcing, and providing oversight and execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
• Implement processes and build a clinical operations organization to successfully plan and conduct multiple clinical trials in early to late stage to achieve pipeline objectives.
• Own patient recruitment strategies, ensuring operational feasibility and timely implementation of study goals.
• Ensure operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials; ensuring all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOP’s.
• Ensure operational feasibility of clinical development plans, including timeline, budget, and resource requirements.
• Ensure that all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs.
• Set the direction of the Clinical Operations organization and lead strategic discussions regarding program and study resourcing.
• Hire, supervise and train operations personnel and assume ownership of the quality of clinical deliverables.
• Procure CRO and vendors and provide oversight throughout the life of all assigned activities Ensure transparency for costs, deliverables, and quality expectations.
• Effectively identify and manage external vendors to provide high-quality deliverables within established timelines and budgets.
• Work collaboratively and communicate effectively with all functional area representatives within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals.
• Develop and implement resource management and trial metric tracking tools.
• Develop and maintain systems for effectively managing service provider relationships. Responsible for instituting a clinical Quality program in collaboration with other functions.
• Be accountable for all relevant timelines and deliverables for the clinical operations department.
• Monitor and keep current on industry best practices, clinical operations practices and changes in regulations and guidelines.
• Define patient recruitment strategies and ensure operational feasibility and timely implementation of the set study goals.
• Work with other Medical/Clinical team members on study documents including clinical trial protocols/amendments, ICFs, CRFs, IND, IB, CRO contracts, study reports, etc.
• Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure clinical operations compliance.
  
  

Qualifications

• 10+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff. Previous experience as a Head of or VP required.
• Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to the conduct of regulated clinical trials, experience in radiopharmaceuticals is strongly preferred.
• Comprehensive understanding of applicable clinical research regulations Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements
• Extensive experience and superior proficiency in designing, managing, and interpreting clinical studies.
• Fluent knowledge of clinical research methodologies and market research strategies.
• Superior proficiency in planning and project organization skills, including risk assessment and contingency planning.
• Demonstrated management, negotiation, and cross-functional collaboration skills.
• Excellent verbal and written communication and presentation skills.
• Demonstrated scientific acumen, demonstrated analytical abilities, sound clinical judgment, scientific credibility, and strong integrity consistent with the company’s values.
• Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
• Decisiveness and the ability to perform as a respected team member and leader.
• Ability to work independently to achieve objectives and lead more than one project simultaneously.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form
• BS or MS in life sciences or healthcare field with additional coursework in clinical trial design and execution.
• Comfortable working is a small start-up resource constrained environment.
• Ability to travel as required (up to 25%).
  
  

What’s In It For You

• Competitive Salary, Bonus, and Equity
• Medical, dental and vision insurance
• Commuter Reimbursement
• Retirement Plan with 3% employer match
• 20 vacation days
• 18 Holidays
• 5 Sick Days
• Short Term Disability
• Long Term Disability
• Life Insurance
• Technology Allowance
• Impactful rewarding work
  
  

Location: San Francisco, CA – Hybrid

• Impactful rewarding work