Director, Clinical Operations

Clinical Research Operations Director 

Vancouver, WA (Onsite), Remote/Hybrid (US-based)

We are seeking a dynamic Clinical Research Operations Director to lead our clinical research initiatives and manage the global operational aspects of our clinical trials. This pivotal role combines the scientific expertise of clinical research with the organizational skills of operations management to ensure the efficient and effective execution of studies across different therapeutic and geographic areas that meet regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences, a deep understanding of clinical trial processes, as well as regulatory affairs to oversee both the scientific and logistical elements of clinical research.

Responsibilities: 

Trial Oversight and Execution:

• Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards.
• Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
• Oversee junior staff assigned to a project, but remain responsible for the success of a clinical project or program.

Operational Management & Compliance:

• Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuringhigh quality, compliance with the study protocol and regulatory requirements across all trials.
• Ensure robust patient recruitment and retention strategies are in place and effectively executed.
• Drive Program level consistency in data collection and compliance
• Drive analysis, troubleshooting, and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies.
• Ensure accurate data collection, documentation, and record-keeping.
• Responsible for the integrity, confidentiality, and security of all research data.

Risk Management & Strategy:

• Identify potential risks and implement contingency plans.
• Keep abreast of industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies.

Collaboration & Communication:

• Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives.

You Will Be Successful If You:

• Effectively build rapport and confidence when presenting trial updates, data, and regulatory information to Clinical Research Investigators and their staff.
• Are an exceptional leader who can successfully coordinate multiple complex clinical projects simultaneously across cross-functional teams to meet aggressive timelines.
• Proactively use your strong analytical and problem-solving abilities to troubleshoot operational issues and interpret clinical data to drive decision-making and project success.
• Demonstrate meticulous attention to detail in all operational and compliance documentation.
• Are adept at collaborating across various departments and with external partners to achieve shared objectives.
• Can manage global projects effectively, navigating multiple time zones and cultural differences in a fast-paced, agile environment.

Qualifications:

• Bachelor’s Degree in life sciences, pharmacology, or a related field.
• A minimum of 8 years of direct experience in the operational management of multi-phase (I-IV) clinical research within the pharmaceutical or biotechnology (including CRO) industry.
• Demonstrated working knowledge of all relevant regulations, including Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Documented experience with or direct involvement in the IND (Investigational New Drug) and CTA (Clinical Trial Application) filing processes.
• Willingness and ability to travel up to 20% per month to oversee clinical trials at investigator sites, attend onsite meetings with vendors, and participate in conferences.

Preferred:

• Experience in immunology, women’s health, and/or dermatology studies.
• Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or a related field.

The salary range for this position is $180,000 - $215,000. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience. In addition to equity, compensation packages include a wide range of medical, dental, and vision benefits and ability to participate in our employee stock purchase plan.

Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, breakfast and lunch for onsite employees, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match. Legal authorization to work in the United States is required.