Associate Director, Clinical Operations (Oncology Experience Required)

Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.

Location: Boston, MA (travel up to 30%)

Job Summary:

In this important role within Clinical Operations, the Associate Director will serve as a leader within the assigned program(s), Clinical Operations department, and Scorpion Therapeutics. The successful candidate will be responsible for planning, execution, and management of complex assignments which may include complex and/or registrational studies, indications, or important cross functional departmental initiatives. The role requires extensive experience in clinical trial operations, particularly in oncology, leadership, and vendor management. The ideal candidate values bringing important medicines to patients in need, and shares our team's determined, positive, flexible attitude.

Role Responsibilities/Accountabilities:

• Capable to independently lead and manage all aspects of clinical trial operations, including planning, execution, and close-out activities.
• Ensure compliance of clinical trials with federal and applicable regulatory agency requirements.
• Develop and maintain clinical trial timelines, budgets, and resource plans to ensure successful project delivery.
• Oversee the selection and management of clinical research organizations (CROs), vendors, and study sites.
• Build effective and lasting relationships with cross functional partners including but not limited to Clinical Science, Regulatory Affairs, Data Management, and Biostatistics, to ensure alignment and successful execution of defined strategies for assigned programs/protocols.
• Provide leadership and mentorship to clinical operations team members, fostering a collaborative and high-performance work environment.
• Oversee clinical trial progress, identify risks, and implement mitigation strategies to ensure timely and high-quality trial execution.
• Prepare and review clinical trial documentation, including protocols, informed consent forms, investigator brochures, and clinical study reports to a high degree of quality.
• Maintain up to date knowledge of industry trends, regulatory requirements, and best practices in clinical operations and oncology.
• Provide updates on study progress to leadership and key stakeholders.

Background/Experience and Education:

• Bachelors degree required, advanced degree preferred.
• Minimum 8 years of experience in clinical operations, with experience leading studies and teams.
• Broad experience leading the execution of clinical trials (i.e., phases of study, end to end experience managing trials, study models) required.
• Biopharmaceutical (Sponsor) organization experience is preferred.
• Demonstrated effectiveness in resolving complex study management issues.
• Successful experience managing a broad project team in a matrix setting is required; direct line management experience is not required.
• Proven ability to successfully manage external vendors required.
• Strong communication, project management, and data analysis skills.
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Prior NDA/BLA submission and health authority inspection experience is preferred.
• Prior experience in Oncology drug development is required
• Up to 30% travel may be required to research sites, investigator meetings or vendor meetings. International travel may be required.

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.