Director 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 Director, Clinical Operations leads and drives clinical studies in conjunction with Clinical Development. This role partners with Clinical Development, Program Management and CMC Operations to define overall strategy toward achieving / exceeding program specific corporate targets, identifying and mitigating potential issues, and ensuring budget and timeline compliance.

This role may involve direct supervision and mentoring of team members as the Clinical Operations team grows.

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

• Provides leadership in the development of clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program lead.
• Lead the CRO / vendor selection strategy to support assigned studies, oversee the documentation for contracting process (SOWs, MSAs, etc.

ensure sponsor oversight, and leverage positive working relationships to enable robust sourcing strategies for future studies.

• Contribute to the design, preparation, and finalization of clinical protocols, study manuals, study reports, and other key operational / regulatory documents.
• Oversees the selection of monitoring resources.
• Ensure adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines.
• Provide input to the drafting of governance documents, SOPs, work instructions, and other resources.
• Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials, operational strategy, risk management and mitigation.
• Provides Clinical Program updates, including trial status / metrics, budget, accomplishments, and risks to CMO, Program Leaders and Managers, the Leadership Team and other relevant stakeholders.

Qualifications :

• Bachelors in Life Sciences with an advanced degree preferred.
• Minimum of 10 years in pharmaceutical / and or biotechnology industry with experience managing clinical trials.
• Working knowledge of ICH and GCP regulations.
• Experience with selection and oversight of CROs / vendors required.
• Experience with early-stage oncology trials required; radiopharmaceutical experience preferred.
• Strong ability to prioritize tasks and keen attention to detail.
• Excellent writing, communication, and presentation skills.
• Demonstrated leadership and project management skills.
• Willingness to roll up your sleeves and get the job done.
• Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.

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
18 days ago