Clinical Research and Operations Manager

Vancouver, WA

Absci is a generative AI drug creation company on a mission to create better biologics for patients, faster. We are the company unlocking the design of new antibodies on a computer from scratch, and we’re just getting started. It will take a state-of-the-art wet lab, artificial Intelligence, and above all else a team of brilliant Unlimiters working together to achieve our vision of breakthrough therapeutics at the click of a button, for everyone. We are gritty, creative, and we are pushing the limits of science in a way that no one has done before because that’s how we will save lives. Join us as we redefine what’s possible.

Absci is a global company with a state-of-the-art lab and headquarters in the beautiful Pacific Northwest US, ten minutes from Portland, Oregon, and its AI Research Lab in the heart of New York City. Check out this short video to learn more and see how #Unlimiters are creating drugs at the speed of AI.

 

Clinical Research and Operations Manager

Vancouver, WA (Onsite), Zug, Switzerland (Onsite), Remote/Hybrid

Our Clinical Research and Operations Manager will lead our clinical research initiatives and manage the 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 areas that meet regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences and a deep understanding of clinical trial processes and regulatory affairs to oversee both the scientific and logistical elements of clinical research.

Responsibilities: 

  • 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.
  • Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
  • Ensure robust patient recruitment and retention strategies are in place and effectively executed.
  • Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials.
  • Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards.
  • Identify potential risks and implement contingency plans.
  • Ensure accurate data collection, documentation, and record-keeping.
  • Support analysis and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies.
  • Keep abreast of industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies.
  • Responsible for the integrity, confidentiality, and security of all research data.

Qualifications:

  • Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field, with a strong foundation in clinical research methodologies.
  • Minimum of 2-3 years of experience in clinical research and operations within the pharmaceutical or biotechnology industry, with experience in immunology being a plus.
  • Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research.
  • Familiarity with the IND and CTA filing process.
  • Exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams in a fast-paced environment.
  • Strong analytical and problem-solving abilities, with a meticulous attention to detail.
  • Demonstrated capability to work collaboratively across various departments and with external partners to achieve objectives.
  • Ability to work in a fast-paced environment and manage multiple projects simultaneously.

For United States Employees the salary range for this position is $130,000- $155,000/year. 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.

We seek candidates who will dive into our creative company culture that’s collaborative, multidisciplinary, and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers, creative scientists, and data-devoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you, we invite you to join us in our quest to redefine possible.

Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Absci offers a dog-friendly work environment - bring your pup along for the ride.

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