Aspen is looking for a highly motivated and self-directed Vice President, Clinical Operations to join its team and set ambitious and visionary targets aligned with key program milestones. Primary responsibilities include clinical study operations, project execution, clinical data management, and team management. Reporting to the SVP, Therapeutic Program Lead, the ideal candidate will have experience leading complex/simultaneous Ph2b/Ph3 clinical trials, have a track record of building strong relationships with KOLs, investigators, and CROs, and an ability to drive a data delivery strategy inclusive of digital health partners.
DUTIES AND RESPONSIBILITIES:
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Set ambitious and visionary vision/goals/targets/KPIs for the Clinical Operations function in the context of the overarching corporate goals
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Establish strategic approach and oversees both in-house and outsourced data management activities to meet needs internally and for external audiences
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Develop, communicate, manage, and deliver on efficient study management, budget, and timelines.
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Manage and execute efficient clinical operations and development programs
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Establish and maintain real-time tracking and monitoring of clinical progress for clinical trial delivery goals and objectives.
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Perform and communicate after-action reviews and project mitigations in real time. Identify, discuss and execute mitigations to ensure successful conduct of the trial.
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Deliver timely clinical trial status updates to senior leadership, highlighting critical challenges and opportunities.
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Select, develop, and manage relationships with CROs, strategic partners, and other vendors as required, to align with contractual expectations and ensure project deliverables.
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Liaise with clinical site staff and investigators as appropriate to ensure optimal sponsor-site relationships and identification of issues/concerns.
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Oversee the creation and maintenance of clinical operations quality systems, including standard operating procedures and policies, document management, clinical operations personnel training, and quality control processes.
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Support the development and maintenance of external clinical operations activities including site training on digital health technology, surgical training protocols and site “center of excellence” qualifications.
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Working closely with the medical function, support the authorship of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary to support regulatory and clinical needs, including FDA filings and Data Monitoring Committee reports.
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Participate in preparation of regulatory filings (e.g. pre-IND, IND, orphan applications etc.) as needed.
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Assess departmental structures and participates in workforce planning activities.
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Develop and manage department staffing plan from recruitment through team development and coaching.
EDUCATION AND EXPERIENCE:
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Bachelor’s degree in a relevant field (Advanced degree preferred)
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A minimum of 15 years’ experience in progressive roles in clinical operations and/or clinical development with trial monitoring responsibilities
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A minimum of 5 years’ experience leading a clinical operations / development team responsible for delivering data for a registrational trial
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Some data management experience is preferred
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Experience managing a CRO for a registrational trial (P2b/3) is required
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Previous experience with Rare Disease /Cell and/or Gene Tx (CGT) is required
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Experience in Neuro and/or Neurodegenerative disorders is preferred
JOB SPECIFICATIONS:
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Clinical Expertise: Proficient in leading registrational clinical development programs.
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Patient-Centric Approach: Ensures patient safety and wellbeing by aligning clinical operations activities with a patient-centric focus.
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Compliance Management: Highly skilled in maintaining adherence to regulatory standards for future filings.
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Detail-Oriented: Pays meticulous attention to details.
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Goal-Driven: Aims to achieve corporate objectives.
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Data-Driven Decision-Making: Analyzes relevant material and develops metrics and dashboards.
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Intellectual Curiosity: Demonstrates a natural inclination toward curiosity and a desire to explore and learn.
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Effective Communication: Facilitates transparent, collaborative discussions for informed decision-making.
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Versatile Communication Skills: Proficient in using tools like PowerPoint, Excel, Smartsheet, MS Projects, and Teams.
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Relationship Building: Seeks win-win solutions and cultivates important relationships with executive-level management and diverse stakeholders (both internal and external)
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Collaborative Approach: Demonstrates transparent, timely, and collaborative engagement to achieve corporate goals.
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Scientific Literacy: Develops strong connections with key opinion leaders (KOLs) and investigators, effectively explaining complex scientific and medical topics relevant to the studies.
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Adaptability: Demonstrates flexibility and adjusts priorities to align with organizational goals, effectively leading and implementing changes to meet program and organizational needs.
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Process Efficiency: Demonstrates a strong orientation toward process efficiency, proactively improving and optimizing key processes to support both current requirements and future needs.
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Cross-Functional Collaboration: Understands the value of respectful and transparent relationships across diverse companywide teams.
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Leadership and Mentorship: Fosters a high functioning team environment centered around growth and development.
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Flexibility for national travel for up to 50% of time
EEO and Employment Eligibility:
Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.
Total Rewards and Culture:
Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.
The anticipated salary range for candidates who will work in San Diego is $275k-$325k annually. The final compensation 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 industry, education, etc. Aspen Neuroscience is a multi-state employer, and this salary range may not reflect positions that work in other states.