Contineum Therapeutics

Lead and oversee clinical development programs, develop portfolio strategy, and ensure operational excellence in a biotech setting. | Extensive experience in biotech/pharma clinical development, leadership in early to late-stage programs, and advanced scientific or medical degree. | The Vice President of Portfolio & Program Management will provide strategic leadership and operational excellence for a growing biotech company focused on developing new therapies for NI&I. A successful candidate will have a foundational expertise in project management, with an established track record in managing all phases of clinical-stage programs, with required experience in early stage through Phase 2, and a proven ability to lead cross-functional teams. This individual must be a strategic thinker with excellent communication and organizational skills to drive our therapeutic candidates toward regulatory approval and commercialization. The Vice President of Portfolio & Program Management will be a key leadership figure responsible for the successful execution of our clinical development programs and with strategic input into the broader portfolio. This individual will oversee all aspects of project management, from strategic planning to operational execution, ensuring that our clinical trials are completed on time, within budget, and in compliance with regulatory standards. The individual (and/or the individual’s team) will work closely with cross-functional teams, including Clinical Research, Clinical Operations, Regulatory Affairs, CMC, and Research, to ensure seamless coordination and communication across the organization. In this role, the VP will drive the coordinated cross-functional execution of programs from early research through clinical development, oversee portfolio strategy, and lead key preclinical and clinical initiatives. The VP will also establish and implement governance structures tailored to the scientific and operational challenges inherent in advancing a varied and high-impact portfolio. Key Responsibilities: Develop and maintain an integrated, data-driven portfolio strategy aligned with corporate vision and scientific priorities Lead portfolio review processes, ensuring timely, evidence-based decision-making and clear resource allocation across programs Evaluate and prioritize internal programs and external opportunities, including partnerships, licensing deals, and platform extensions Conduct scenario planning, risk assessments, and investment trade-off analyses to guide strategic direction Oversee or directly lead key development programs spanning discovery, preclinical, and clinical stages Drive creation and execution of integrated, cross-functional program plans encompassing research, translational, clinical, regulatory, CMC, and commercial considerations Ensure programs meet timelines, budgets, and milestones; actively identify risks, dependencies, and mitigation strategies Maintain transparent reporting systems and dashboards for executive leadership, governance committees, and the board Partner with Research, across Clinical Development functions, and with other internal teams to ensure alignment and operational excellence Facilitate clear communication and decision-making across all program teams Support readiness for key milestones such as IND submissions, clinical trial initiations, regulatory interactions, and strategic partnerships Together with the CMO, establish and refine clinical development team and governance frameworks that enable efficient and high-quality development activities, clear decision-making structures, that facilitate clear communication and a documented alignment in R&D strategy Build and mentor a high-performing PPM function tailored to the needs of a small, rapidly growing biotech Implement best practices in project planning, resource management, and cross-functional communication Champion a culture of accountability, transparency, and collaboration across the organization Advanced degree in a scientific or medical discipline relevant to inflammation, immunology, and/or fibrosis or to drug development (PhD, MD, PharmD strongly preferred) 15+ years of experience in biotech/pharma, including significant time leading development programs in inflammation, fibrosis, immunology, and/or neurosciences – experience specific to pulmonary fibrosis is viewed positively Demonstrated success managing programs from Pre-IND, through Phase 2 and Phase 3 registrational trials; experience in early through or mid to late-stage clinical development is required Excellent leadership, communication, and organizational skills, with the ability to operate effectively in a small, fast-paced biotech environment 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 or Seattle, WA is $240,000- $270,000. 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.

Lead and develop the company's quality function ensuring compliance with global GXP standards, managing quality systems, and leading audits and inspections. | Minimum 15 years of experience in biotech or pharmaceutical quality leadership, with strong knowledge of GXP regulations, quality risk management, and team management. | The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Key Responsibilities: Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards Ensure the appropriate identification, evaluation, and management of risks associated with quality Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment. Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation Create and implement risk-based quality strategies that identify and address potential quality risks Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities Build, mentor and provide leadership and direction to the quality assurance team, ensuring that all quality activities are carried out efficiently and effectively as the need develops for a team BS/BA in biology or related Life Sciences discipline, or equivalent experience Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines Expertise in Quality Management Systems (QMS) Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff Demonstrated ability to lead and motivate cross-functional teams Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team Ability to travel 15% We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. 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.

Managing clinical studies from start-up to database lock, overseeing vendor activities, and ensuring regulatory compliance. | Minimum 5 years in clinical development, Bachelor's or higher in a scientific discipline, proficiency with standard software platforms, strong organizational and communication skills. | The Clinical Project Manager (CPM) will be responsible for independently managing internal and outsourced (CRO) aspects of US and/or global clinical studies. The CPM will report to a Director-Level team member in Clinical Operations. The ideal candidate would reside on the West Coast of the United States and could come into the San Diego office monthly or work hybrid if local. Key Responsibilities Contribute to the planning, execution, and oversight of aspects of global and/or regional clinical studies from study start-up through database lock and final CSR Ensure timely delivery of key clinical trial deliverables and milestones, including site selection and activation, FPI, LPI, subject retention, data review, database lock, site closeout, TLF delivery, CSR, and TMF delivery Closely oversee and coordinate vendor activities. Contribute to vendor selection and management. Act as a primary point of contact between the sponsor and CROs or vendors. Coordinate problem-solving of vendor, site, and internal issues Contribute to the development of clinical protocols. Review informed consent forms, case report forms, study plans and other documents for harmonization and consistency. Comply with internal SOPs, ICH/GCP guidelines, and other regulatory requirements Communicate study status and escalate issues to clinical management and the organization cross-functionally as required Collaborate with internal stakeholders to ensure mutual cross-functional support to meet company objectives Plan, prepare, and present as needed at internal and external meetings Bachelor's or higher degree in a scientific discipline Minimum of 5 years of experience in clinical development with experience in clinical operations preferred Proficiency with standard software platforms Dedication to quality and reliability, including thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines Strong organizational and multitasking skills Excellent written and verbal communication and interpersonal skills. Friendly, with the ability to develop collaborative relationships in an often remote online team environment We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $152,000. 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.

Lead and develop the Biometrics department, oversee biostatistics activities supporting clinical development, and ensure regulatory compliance. | Ph.D. in Statistics or related field with 15+ years in pharmaceutical industry, expertise in regulatory guidelines, and experience in clinical trial phases 1-4. | The Head of Biometrics will be responsible for the strategic positioning and tactical advancement of Biostatistics and Data Management. The position will report to an executive leader at Contineum Therapeutics. This role will be accountable for all Biostatistics technical plans and analyses, Data Management functions, Statistical Programming functions, and Clinical Systems. The Head of Biometrics will support the development and documentation of procedures and policies for operations and participate in establishing drug development strategy and direction. This role will work closely with other clinical development functional area representatives and participate in strategizing and executing clinical development programs with a strong technical, regulatory, and scientific foundation. Key Responsibilities: • Define and execute the strategic vision for the Biometrics Department. • Establish organizational structure for the Biometrics Department, including Statistical Programming, Data Management, and Clinical Systems functions. Lead and develop Biometrics employees. • Oversee and coordinate and be directly responsible for all biostatistics activities to support clinical development projects, delivering study designs and analysis plans, ensuring sound biostatistics principles and compliance with regulatory guidelines. • Advise on statistical issues associated with the design and analysis of clinical trials and provide biostatistics input on all major documents, including clinical development plans, protocols, data collection methodologies, statistical analysis plans, clinical study reports, and summaries of clinical safety and efficacy for regulatory filings. • Guide the application of epidemiologic methods to analyze observational/real-world data to calculate appropriate sample sizes, strengthen submission evidence and support drug development. • Provide review and guidance on statistical aspects, new programming, database technologies, clinical systems, and standards of all FDA/EMEA regulations and ICH & GCP guidelines. • Serve as the senior biostatistics representative supporting protocol/clinical document review, strategic and partner joint development activities, drug safety, and publication activities. • Collaborate with other senior development leaders to ensure consistency of development work standards, intellectually challenging assumptions, and sharing ideas. • Provide leadership for sponsor/CRO activities, relationships, and escalation resolution. • Interact as required with FDA/EMA and other health authorities to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development. • Support the development and implementation of best practices, SOPs, standards, work instructions, and policies for biostatistics. • Ph.D. in Statistics or related fields and 15+ years of pharmaceutical industry experience, or Masters in Statistics and 20+ years of comparable experience. • Expert knowledge of ICH and other regulatory development guidelines. • Experience in recruiting, coaching, and developing talented team members. • Deep understanding of mathematical and statistical principles; demonstrated proficiency in at least one statistical analysis software (SAS preferably). Knowledge of other statistical software is a plus. • Experience in Phase 1-4 clinical development of a wide range of therapeutic areas, direct experience in pulmonary disease (i.e., idiopathic pulmonary fibrosis) is a plus. • Stellar communication and presentation skills. Must be able to articulate with non-statisticians to interpret and explain statistical findings. • Excellent organizational and problem-solving skills. • Proven leadership skills and must work effectively in a team environment. • Expertise in biostatistics procedures and alignment with regulatory requirements. • 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. We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $340,000. 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.