Allakos Careers

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.


Assistant Controller or Controller


Exciting private life sciences company with two products in clinical trials seeks assistant controller or controller to support the growth of our financial operations as our company advances our groundbreaking products for serious unmet medical needs.

  • Responsible for all aspects of accounting operations including GL, AP, monthly and quarterly closes, documentation and control systems
  • Coordinates audit; assures efficient audit support
  • Ensures compliance with generally accepted accounting principles (GAAP)
    • o Including clinical trial accrual model maintenance
  • Ensures prompt and accurate tax filings and, where relevant, payments, including for property tax filings, sales and use tax filings and, for state and federal, provides PBCs to the tax filing preparation firm
  • Prepares monthly management reports and supports FP&A
  • Supports department leaders with forecasts and variance analyses as well as operations
  • Partners with senior leadership on organization's financial operations

Requirements

  • Bachelor’s degree in accounting or finance
  • Higher certifications, such as CPA
  • 15 years experience in accounting operations or audit and operations
  • Strong communication skills
  • Strong management skills and leadership qualities
  • Fastidious attention to detail
  • Life Sciences helpful important but not required

Scientist/Senior Research Associate in Immunology/Pharmacology


Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit a senior scientist/ associate director in Research Immunology. The ideal candidate will possess the following:

  • Ph.D. in biological sciences with relevant experience in immunology
  • B.Sc. with more than 3 years of relevant experience in immunology
  • Hands-on expertise with in vivo models of allergic or inflammatory disease, fibrosis or COPD
  • Experience in working with primary human cells and lines
  • Excellent organization and troubleshooting skills
  • Strong interpersonal communication skills
  • Ability to work cooperatively in a team-based environment

Responsibilities:

  • Conduct chronic models of allergic and inflammatory disease and fibrosis
  • Design and execute functional and characterization assays on diverse human and murine primary cells and cell lines

The salary is competitive and commensurate with experience and qualifications.