Allakos Careers


Clinical Study Manager (CSM)/Sr. Clinical Study Manager, Clinical Operations

Department: Clinical


The Clinical Study Manager (CSM) will be responsible for the operational management, including documentation and reporting requirements of clinical studies. The CSM will work closely with the Program Managers, VP Clinical, CMO, Regulatory and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.

Ideal Candidate:

  • Experience managing or supporting management of global Phase I-II clinical trials is highly desirable, particularly with focus on respiratory, immunology, orphan diseases and oncology.
  • Experience working with clinical operations study teams including CROs and other vendors.
  • Excellent interpersonal skills, strong written and verbal communication/presentation skills.
  • Ability to work independently in a start up environment with minimal supervision.
  • Must possess excellent project management skills and In-depth knowledge of ICH GCP guidelines.
  • Bachelors required (advanced degree preferred) with at least 7 years experience in clinical operations program management within a Bachelors required with at least 2-3 years relevant experience in clinical study or site management within a Pharmaceutical, Biotechnology company or at a CRO.

Primary Responsibilities and Duties:
Key responsibilities include but not limited to:

  • Support and manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports.
  • Manage study sites and train clinical site staff to ensure protocol and regulatory compliance.
  • Participate in CRO selection, development of RFPs, budget negotiations, and CRO management.
  • Responsible for clinical site budget and contract negotiation.
  • Planning, monitoring, and managing budgets for clinical studies.
  • Participate and provide guidance for monitoring plans, coordinating study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA).
  • Interact with investigators and thought leaders for protocol development, presentations and publications.
  • Participate in monitoring visits, including Site Qualification and Site Initiation, as needed.
  • Review and support development of SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials.
  • Help establish systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
  • Responsible for clinical Trial Master Files according to applicable domestic and/or international regulations and internal SOPs.
  • Support design of appropriate clinical trial studies in support of drug development.

Minimum Education: Bachelor's Degree in a scientific discipline.
Knowledge of and competence in application of CFRs, GCPs and ICH Guidelines and demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, Power Point) and computer skills.

Experience: A minimum of 3+ years of industry experience, including at least 2+ years of direct clinical study management or support experience. Early phase (Phase 1 to 2) development experience is preferred.

Must be able to travel (approx. 25%) as required for the project.

NOTE: The level of this position will be determined based on the candidate's qualifications and experiences.

We are an equal opportunity employer.


Assoc. Director/Director, Clinical Operations

Department: Clinical


The Director Clinical Operation will be responsible for the operational management, including documentation and reporting requirements of a clinical development program. The Director will work closely with the VP of Operations, CMO, Regulatory and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.

Ideal Candidate:

  • Experience managing global Phase I-II clinical trials is highly desirable, particularly with focus on respiratory, immunology, orphan diseases and oncology.
  • Experience leading, managing, and providing guidance to clinical operations study teams including CROs.
  • Excellent interpersonal skills, strong written and verbal communication/presentation skills necessary to meet the needs of various audiences.
  • Ability to work independently in a start up environment with minimal supervision.
  • Must possess excellent project management skills and In-depth knowledge of ICH GCP guidelines.
  • Bachelors required (advanced degree preferred) with at least 7 years experience in clinical operations program management within a Pharmaceutical, Biotechnology company or at a CRO.

Primary Responsibilities and Duties:
Key responsibilities include but not limited to:

  • Provide oversight and leadership to the cross-functional study team(s).
  • Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports.
  • Manage study sites and train clinical site staff to ensure protocol and regulatory compliance.
  • Responsible for CRO selection, development of RFPs, budget negotiations, and CRO management.
  • Responsible for clinical site budget and contract negotiation.
  • Planning, monitoring, and managing budgets for all clinical operations.
  • Participate and provide guidance for monitoring plans, coordinating study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA).
  • Interact with investigators and thought leaders for protocol development, presentations and publications.
  • Participate in monitoring visits, including Site Qualification and Site Initiation, as needed.
  • Planning resources and tasks to meet corporate goals for timely initiation and completion of clinical studies.
  • Develop and review SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials.
  • Establishing systems for tracking of various activities during clinical trials, e.g., tracking of clinical reviews, data query resolution, etc.
  • Develop Clinical Trial Master Files according to applicable domestic and/or international regulations and internal SOPs.
  • Support clinical development through interaction with Key Opinion Leaders and Scientific Advisors in order to design appropriate clinical trial programs from Phase 1-2 clinical trials.

Minimum Education Typically Required: Bachelor's Degree in a scientific discipline (Advanced degree preferred) Knowledge of and competence in application of CFRs, GCPs and ICH Guidelines and demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, Power Point) and computer skills.

Amount of Experience Typically Required: A minimum of 7+ years of industry experience, including at least 4+ years of clinical trial and program management experience. Early phase (Phase 1 to 2) development experience is preferred.

Must be able to travel (approx. 25%) as required for the project.

NOTE: The level of this position will be determined based on the candidate's qualifications and experiences.

We are an equal opportunity employer.