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.

Location: San Diego, CA or Remote
Schedule: Hybrid and/or Remote

Company Overview:
Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel, oral small-molecule therapies for neuroscience, inflammation, and immunology (NI&I) indications with high unmet needs. We target biological pathways associated with specific clinical disabilities, aiming to impact the course of disease. In addition to multiple indications within neuroscience, our pipeline includes programs for idiopathic pulmonary fibrosis (IPF), as well as other possible fibrotic disorders.

Job Summary
The Medical Director reports to the Chief Medical Officer and will be responsible for contributing to the clinical development strategy and providing medical support for the execution of clinical trials/clinical research related to IPF  and other non-CNS disorders. The successful candidate will additionally be responsible for supporting the development and clinical expansion of our novel therapeutic candidates.

Key Responsibilities:

• Provide insights and clinical/medical perspective into ongoing and planned research and development strategy.
• Oversee, establish, and approve scientific methods for the design and implementation of clinical protocols, data collection systems, and final reports for the company’s product candidates.
• Serve as a medical representative of the company both internally and externally (scientific community and key experts).
• Provide medical review, assessment, and interpretation of all clinical data to ensure that the data is presented with the appropriate medical interpretation.
• Responsible for medical monitoring of human clinical trials for company products under development, including determination/confirmation of subject eligibility.
• Responsible for medical review of adverse event reporting and safety monitoring.
• Contribute to the Identification and selection of appropriate clinical investigators to perform studies.
• Cultivate relationships with global Key Opinion Leaders in academic and clinical medicine.
• Maintain an understanding of competitors and disease-specific clinical developments.

Minimum Requirements:

• Candidate must have an MD and a minimum of 5 years of experience in the pharmaceutical industry, biotechnology industry, and/or clinical research at a leading academic institution.
• Advanced training in critical care medicine, pulmonary medicine, or related fields is preferred.
• An outstanding track record of achievement in the clinical development of therapeutic products, particularly in neurology or pulmonology.
• Experience in designing and implementing all phases of clinical studies.
• A proven ability to perform in-depth research, analysis, and interpretation of medical data.
• Thorough knowledge of FDA requirements and regulatory strategies.
• A proven ability to assemble evaluated information into an accurate, comprehensive, and concise standard medical response document or dossier.
• Excellent verbal and written communication, presentation, and customer service skills.
• An ability to embrace the importance of teamwork and show strong interpersonal skills and accountability.
• Must have demonstrated ability to be flexible and multitask in fast-paced, high-pressure, changing conditions.

Compensation and Benefits:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $260,000-290,000. 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.

Location: San Diego, CA
Schedule: Remote and/or Hybrid

Company Overview:
Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel, oral small-molecule therapies for neuroscience, inflammation, and immunology (NI&I) indications with high unmet needs. We target biological pathways associated with specific clinical disabilities, aiming to impact the course of disease. Our pipeline includes multiple neuroscience-related indications, as well as programs for idiopathic pulmonary fibrosis, and potential other fibrotic disorders.

Job Summary:
The Director of Clinical Data Management will support Clinical Operations and Biometrics to ensure completeness, accuracy, and consistency of clinical data and data structure. This role involves oversight of CRO clinical data management activities, detailed data review, and collaboration with cross-functional teams to meet project deliverables and timelines.

Key Responsibilities:

• Participate in the CRO selection for DM activities (review of proposals, bid defense).
• Provide oversight of CRO clinical data management (CDM) activities for assigned studies.
• Manage URL ownership and user permissions for all clinical studies.
• Review and provide feedback on CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements, and data validation specifications.
• Assure case report forms (CRFs) are designed and developed in accordance with study protocol and other supporting documentation.
• Oversee electronic data capture (EDC) database build process, including review of specification and data validations documents.  Review user acceptance testing (UAT) plans and participate in UAT of IRT, EDC, ePRO, eDiary, and other data systems during initial build and subsequent modifications.
• Perform detailed and thorough data review of clinical trial data as needed.
• Represent Clinical Data Management (CDM) at relevant internal and external team meetings.
• Assure timeliness of deliverables (database build, testing, go-live, cleaning, and lock) and manage CRO accordingly.
• Communicate clinical trial status, milestones, and deliverables throughout the duration of the study.
• Contribute to Clinical Data Management Department improvement/enhancement initiatives. Participate in the development and implementation of new technology or tools. Develop core SOPs and templates.
• Supervise clinical data management activities. Perform direct negotiations with the CRO for timelines, processes, and quality issues.
• Provide support for sponsor clinical data medical review.
• Escalate unresolved data or compliance issues to the functional manager(s); work with CRO data managers, partners, vendors, and internal team members for resolution.
• Provide support or assist the Quality Assurance department in conducting audits involving data management activities.

Education and Experience:

• Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
• 10-15+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of the clinical drug development processes required. NDA submission experience a plus.
• Thorough knowledge of Medidata RAVE (super user status preferred)
• Thorough knowledge of CDISC standards, SDTM and ADAM datasets
• Consistent, detail-oriented, communicative, dedicated, and accountable. Strong verbal and written communication skills.
• An ability to embrace the importance of teamwork and show strong interpersonal skills and accountability.
• Must have demonstrated ability to be flexible and multitask in fast-paced, high-pressure, changing conditions.
• CRO and vendor oversight experience preferred.
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).

Compensation and Benefits:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates who will work in San Diego, CA is $215,000 – $240,000 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 toinfo@contineum-tx.com.