SiteOne Therapeutics is a clinical-stage biopharmaceutical company advancing a novel class of highly selective small molecule inhibitors targeting NaV1.7, NaV1.8, and other ion channels to treat pain, cough and other conditions involving hyperexcitability of the peripheral nervous system. Since its inception, SiteOne has been dedicated to the development of safe and effective pain therapeutics without the significant addiction potential and side effects of opioids. The company is also advancing additional novel drug candidates that exhibit precise selectivity for individual ion channel subtypes to treat other sensory hyperexcitability disorders such as chronic cough and chronic ocular surface pain.

Summary

We are currently searching for an experienced professional to join our team as Senior Director, Data Management.

Reporting to the Chief Medical Officer (CMO), the Senior Director will provide oversight to Data Management operations in support of clinical development activities, including evaluating and recommending new technologies for implementation to maintain industry standards and to improve operational efficiency, ensuring compliance with applicable regulatory requirements, and assessing new SOPs and Guidance documents prior to approval and implementation.

Key Responsibilities

• Develops and maintains working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
• Establishes and manages data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
• Provides consultation, leadership, and expertise to clinical development functions in data handling and data management processes.
• Evaluates Electronic Data Capture (EDC) and eSource technologies for implementation.
• Develops Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and in harmony with developing industry standards (CDISC).
• Helps support and implements SDTM data standards for all studies
• Manages projects assuring timeline and budgetary compliance.
• Participates in the development and maintenance of standard CRFs and eCRFs and associated edit specifications.
• Manages Data Management staff to support clinical development programs including communicating department vision and expectations aligned with corporate goals for each direct report.
• Train and orient new employees on corporate culture, corporate expectations and departmental/organizational policies and procedures. Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.
  
  

Qualifications

• Minimum bachelor's degree required, Advance degree preferred. A degree in Biomedical is preferred.
• Minimum of 12 years of relevant experience required.
• Pharmaceutical/Biotech experience is required
• Advanced knowledge of data management process for clinical trials and the applicable regulations
• Willing to be hands for the data management activities
• Good working knowledge in MedDRA and WHO drug coding, capable of doing coding or coding review. Help establish code review.
• Expert level skills using computer systems in data management process, EDC, eSource and data management software
• Advanced knowledge of clinical data warehouse systems
• Advanced knowledge with ICH/GCP/CFR guidelines as applicable to global Data Management projects (Phase I-IV)
• Advanced project management, prioritization, and organizational skills, and communication skills
• Expertise in the implementation of electronic data capture systems used in clinical studies
• Experience in managing and overseeing Clinical Research Organization activities in data management function
• Up to 20% travel may be required based upon business needs
  
  

Compensation offered will be determined by factors such as location, level, job-related knowledge, skills, and experience.

SiteOne Therapeutics is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Agency Disclaimer: SiteOne Therapeutics does not accept unsolicited resumes from recruiters or agencies. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Therefore, please do not submit resumes unless authorized. SiteOne Therapeutics will not pay any fees related to unsolicited resumes, including those submitted to hiring managers.

Base Salary Range

$255,000—$275,000 USD