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Senior Clinical Study Manager

Employer
AnaptysBio, Inc.
Location
San Diego, CA
Start date
Feb 25, 2024

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

Position Summary 

This position is accountable for all operational activities related to planning, executing/conducting and reporting out of assigned clinical study in support of AnaptysBio product development portfolio. The Senior Clinical Study Manager (Sr. CSM) will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Duties involve contributions to multiple clinical studies of differing phases, project planning, budgeting, participating in the selection of clinical sites, selection and management of clinical vendors, organizing and conducting Investigator Meetings, making clinical presentations, etc. The successful candidate drives the conduct of the study, maintains study level reporting systems, progress reports and trackers to ensure all study operational aspects are on track in support of AnaptysBio clinical programs. 

 Essential Functions: 

  • Effectively manage multiple studies and/or programs simultaneously to ensure time, quality, and cost metrics are adequately defined and met. Identify and manage potential risks and impacts with regard to: 

               - Site identification/qualification 

               - Site start-up and initiation (e.g., CTAs, Study budgets, Enrollment/Retention Plans, Monitoring Plans)

               - Study conduct 

               - Data collection, management, and analysis

               - Final data/reporting 

  • Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs 
  • Execute study management with thorough understanding of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA) and applies this knowledge to all aspects of the study (startup through conduct to closeout) 
  • Participate in study center selection, pre-study qualification, initiation, and closeout.
  • Coordinates and conducts study monitoring with CRAs to ensure study compliance, data quality, proper documentation and study completion. 
  • Oversees plans and preparation for/of Essential Documents (e.g., Patient Informed Consent Forms, 1572s,) 
  • Identify, manage and supervise clinical CRO and consultant activities. 
  • Negotiate clinical trial agreements and budgets; manage the budget and vendor site payments. 
  • Participate in developing study-related documents such as protocols, SOPs, work instruction documents, informed consent forms, and case report forms (CRFs), etc. 
  • Participate in the preparation and writing of Investigator’s Brochures and clinical sections of regulatory documents such INDs, DSURs, NDAs, etc. (and/or international equivalents). 
  • Participate and support publications based on the clinical program.
  • Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance, etc.) to ensure all stakeholders are informed of and aligned with clinical activities. 
  • Recommend and implement innovative process ideas that impact clinical trials management and cost efficiency. 

Supervisory Responsibilities:

  •  None 
Requirements

Education and Experience:

  •  BA/BS in related scientific or healthcare field and 
  •  Six years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology, allergy, dermatology and/or biologics experience. 
  • CCRA preferred.

Knowledge and Competencies: 

  • Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs
  •  Proven ability to plan, conduct and manage clinical operations from early through late phase trials, with global trial experience is preferred. 
  • Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors. 
  • Ability to contribute to the development of clinical protocols, project-related documents, clinical study  reports and summary documents for regulatory submissions. 
  • Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
  •  Demonstrated, effective planning and project management skills, including risk assessment,  contingency planning and ability to prioritize.
  • Effective communication and interpersonal skills, with the ability to successfully articulate plans,  results and analysis to project teams and senior management to build commitment and alignment;  listens and seeks clarification; responds effectively to inquiries or complaints. 
  • Ability to build strong relationships with external parties, such as key opinion leaders and clinical  investigators. 
  • Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines. 

 All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.  

Salary Description $133k-$175k, 15% bonus, 10% 401k, Options & RSU

Company

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. We are developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, our PD-1 agonist program in a Phase 2 trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, our BTLA agonist program, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Our preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Our corporate vision is to transform patient health by delivering innovative immunology therapeutics. Find out more about us by following us on Twitter.

 

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Company info
Website
Phone
858-362-6295
Location
10770 Wateridge Circle
Suite 210
San Diego
California
92121
United States

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