Director Clinical Operations & Project Management

Director – Clinical Operations & Project Management

Manager: Chief Medical Officer, Seraxis Inc.

Position Description:

The Director, Clinical Operations & Project Management will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Director, Clinical Operations will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and SOPs. This role will work closely and collaboratively with inhouse and contracted functional areas including Medical, Medical Writing, Biostatistics, CMC, Drug Safety and Regulatory as well as Clinical Research Organizations, to ensure the timely execution of studies within budget.

Job Responsibilities:

Major job responsibilities include but are not limited to the following:
Clinical Operations:

• Leads management and execution of all clinical trials.
• Provides strategic and technical guidance to ensure that clinical trials are properly defined,
  planned and executed.
• Collaborates with the appropriate functions in defining the outsourcing strategy for the
  development program(s).
• Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation
  strategy, and oversight of operational vendors (e.g., monitoring, labs, imaging, etc.).
• Assists in the authoring of key regulatory documents (e.g., CTD, pre-meeting materials and
  briefing packages), study protocols, investigator’s brochures, annual IND progress reports, study
  postings, and CSR for consistency across programs.
• Develops in-depth knowledge of the clinical data and assures appropriate transfer of that
  knowledge to cross-functional study teams to achieve operational excellence.
• Ensures that external vendors are selected and managed to deliver within established timelines
  and budget. This also includes site qualification and initiation.
• Supports the creation of clinical operations Standard Operating Procedures (SOPs), systems, and
  processes across the trials; ensures compliance with regulatory and other applicable standards
  and guidelines.
• With the CMO, collaborates with KOLs for feedback on study protocols and development plans.

Project Management:

• Responsible for integrating inputs across development functions to ensure a comprehensive, integrating development strategy.
• Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
• Translate proposed strategies into operational plans, including timelines, budgets, and resource requirements; highlight key milestones and risks to CMO and team members as needed.
• Ensures consistency and coordination across functions, including aligning timelines and connecting elements of the development plan to one another.
• Responsible for creating and updating Timelines in both detailed (e.g. Gantt) and high level (e.g. PowerPoint) summaries.
• Ensure that high operational standards are maintained across clinical program and drive operational excellence activities, including program and trial metrics, communication platforms, and process improvement initiatives.

Skills & Qualifications:

• 10+ years’ experience of strong hands-on experience leading clinical trials execution.
• 5+ years managing cross-functional development teams or managing clinical operations for
  multiple clinical trials.
• 5+ years’ experience in Project Management.
• Diabetes, specifically Type 1 Diabetes therapeutic area experience a plus.
• Proven ability to build strong relationships with external partners, CROs, and vendors including
  extensive experience managing contracts and clinical finance activities.
• Analytical thinker with excellent problem solving skills and the ability to adapt to changing
  priorities and deadlines.
• Excellent planning, organization and time management skills.
• Knowledge of relevant pharmaceutical quality and regulatory standards requirements.
• Proven track record of project and/or operational support for successful IND, CTA, NDA, and/or
  BLA regulatory submissions.
• Extensive experience in delivering clinical study reports with complete appendices, CRFs and
  electronic datasets.
• Ability to accurately project budgets and manage them across studies and projects.
• Proficient in use of electronic clinical database software and other programs such as Microsoft
  Office, Gantt, WORD, Excel, Adobe Acrobat.
• Flexibility to travel as required.

Education and Training:

• Undergraduate degree in Life Sciences or Pharmacy a plus.
• Advanced degree preferred.
• Project Management and Clinical Operations Certification a plus.
• Experience in Cell and Gene therapy a plus.

Cultural & Competency Expectations:

• Excellent listening, communication (written, spoken) and interpersonal skills, fostering team spirit.
• Consistent delivery of high quality work at all times.
• Effective communication and interpersonal skills; effective interaction with senior management.
• Ability to take a leadership role, motivate staff, and drive high quality execution.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment
  consisting of internal and external team members.

Compensation: Competitive compensation and benefits package, including participation in stock option plan

Seraxis is an Equal Opportunity Employer. Please email cover letter and resume to info@seraxis.com.