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Vice President Clinical Operations - San Francisco, United States - Alpha-9 Oncology
Description
This range is provided by Alpha-9 Oncology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range
$300,000.00/yr - $350,000.00/yr
Additional compensation types
Annual Bonus and Stock options
Direct message the job poster from Alpha-9 Oncology
Senior Human Resources Executive | Talent Management | Culture Champion | Change Management | Employee Engagement Evangelist | Strategic Partner
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.
Qualifications
BS or MS in life sciences or healthcare field with additional coursework in clinical trial design and execution.
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 and thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
Extensive experience and superior proficiency in 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.
Comfortable working is a small start-up resource constrained environment.
Ability to travel as required (up to 25%).
Seniority level
Seniority level
Executive
Employment type
Employment type
Full-time
Job function
Job function
Other
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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