Location: San Diego, CA
Schedule: Remote or Hybrid
Company Overview:
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need. Contineum is advancing a pipeline of internally developed programs with multiple drug candidates now in clinical trials. PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis, progressive multiple sclerosis, and chronic pain, and PIPE-307 is a selective inhibitor of the M1 receptor in clinical development for relapsing-remitting multiple sclerosis and major depressive disorder.
Job Summary:
Independently manage internal and outsourced (CRO) aspects of US and/or global clinical studies.
Key Responsibilities:
- Ensure timely delivery of milestones, including protocol development, site selection and startup, enrollment, subject follow-up, database lock, site closeout, TLF delivery, and CSR.
- Closely oversee and coordinate vendor activities, including vendor selection and definition of scope. Create POs and review and approve invoices.
- Facilitate quality deliverables within established timelines. Review and approve vendor-sourced case report forms, study procedures, plans, manuals, and other documents.
- Ensure compliance with corporate SOPs and health authority, ICH/GCP, and local regulations and guidelines.
- Facilitate internal development of clinical trial protocols, periodic reports, CSRs, registry postings, and other sponsor documents.
- Communicate study status and escalate issues to clinical management and the organization cross-functionally. Collaborate with cross-functional project team to ensure drug supply and regulatory coordination. Drive problem-solving of vendor, site, and internal issues.
- Plan, prepare, and present as needed at vendor and investigator meetings.
- As needed, provide leadership and guidance, expertise, and mentoring to junior staff.
Education and Experience:
- Bachelor’s or higher degree in a scientific discipline
- Minimum of 5 years of experience in clinical operations or related clinical development. Ex-US, early Phase, CRO/vendor management, CNS indications, and small company experience all pluses
- Dedication to quality and reliability, including thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines
- Excellent interpersonal skills. Friendly, with the ability to develop collaborative relationships in an often remote online team environment
- Clear and concise verbal and written communication skills
- Strong organizational skills, with attention to detail
- Ability to prioritize and handle multiple tasks simultaneously
- Proficiency with standard software platforms
- Proactive, hands-on, can-do approach and ability to thrive in a dynamic start-up environment
- Travel within the US generally up to 10%, and more during study startup phases.
Compensation and Benefits:
We offer a competitive total compensation package and work in a supportive team environment. The anticipated salary range for candidates who will work in San Diego, CA, is $125,000 – $145,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:
- 90% employer-covered benefits
- Flexible PTO
- A very generous holiday schedule that includes a week off in August and time off around the winter holidays
- A well-stocked kitchen with snacks and beverages
- Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
- The comprehensive wellness program includes medical, dental, vision, and LTD coverage.
How to Apply:
Please submit your resume or CV and supporting documents to info@contineum-tx.com.