Leads and drives all operational and administrative functions in therapeutic area clinical programs by ensuring the execution of clinical studies to successfully register new products/indications. Exercises a high degree of quality, productivity and communication to the department and therapeutic area for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices.
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The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
This position strongly influences Therapeutic Area Heads, Project Team Leaders, Clinical Subteam Leaders, Data Manager, Regional Site Manager, Regulatory Leaders, Global Compliance and Training, etc.
Main Areas of Responsibilities
· Works collaboratively with other Program Operations Leads to agree upon processes, systems and procedures to lead Global Clinical Trial Management teams. Direct and leads the operations for multiple global therapeutic area clinical programs which includes implementation study protocol ensuring patient enrollment has met study goals. Provides feedback to TA on operational aspects of protocol design. Acts as a resource for operational process improvement ideas and targets. Serves as content expert in execution of clinical operations. Provides guidance in development and modification of clinical timelines and resource requirements. Ensures appropriate number of staff with appropriate skills, knowledge and experience are assigned to study. Ensures proper metrics and diagnostics are utilized to ensure staffing levels meet study requirements and also reallocates staff to priority projects within Global Clinical Trial Management. Works collaboratively with Therapeutic Areas to ensure study design and critical study decisions are made collaboratively to ensure study success. Performs other duties as assigned.
· Ensures operations team, locally and/or globally as appropriate, follow any and all SOP’s, policies and regulatory requirements. Also works in tandem with other Program Operations Leads to ensure consistent processes are collectively agreed upon and followed by all Global Clinical Trial Management team members. Ensures timely communication and problem resolution occurs when study progress may not be meeting study goals. Ensures documentation and reporting occur in a timely manner. Ensures appropriate global tracking and management of study is occurring. Provides operations services to Clinical Leads and Project Team Leaders. Operationally leads clinical research teams to rapidly deliver operational excellence for new projects or indications that meet minimum and desired characteristics for worldwide registration. Ensures all regulatory requirements are adhered to when applicable. Proactively plans study prioritization, budgetary requirements and goal attainment. Ensures consistency with processes and procedures.
· Provides leadership and direction to operations teams in locally and/or globally. Properly analyzes staffing needs to ensure studies are staffed accordingly. Also ensures staff are coached and developed for optimal performance and are current with new SOPs, policies, processes and regulatory requirements.
· Provides timely feedback, coaching and counseling in partnership with Human Resources to ensure staff is performing their responsibilities at the most optimal level. Promptly deals with performance issues to minimize disruptions. Provides timely communication to staff members on all relevant matters, provides leadership to minimize distractions and disruptions. Ensures all performance evaluations are conducted in a timely manner. Collaboratively allocates resources based upon employee development needs, study staffing needs and other business requirements.
· Assists in the development of operations budgets ensuring program needs are identified in budget. Ensures study budgets are managed without overages or discrepancies.
· The role is responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work
· Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Other activities, special projects and assignments may be given as required.
Requirements
· Bachelor’s degree with experience in a relevant field
· Minimum 13 years of experience working in a clinical operations organization, preferably within pharma or CRO.
· Minimum of 13 years of experience working in clinical research with a strong understanding of the clinical and drug development process
· Minimum 8 years leading and managing highly diverse and educated teams
· Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
· Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies Good understanding of drug development process, including preclinical.
· Demonstrated understanding of risks to CROs’ businesses and how they might be impacted by Allergan.
· Demonstrated strong networking both internally and externally.
· Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences.
· Strong interpersonal skills and ability to confront issues with CROs and Allergan staff for a win-win outcome.
· Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality.
· Demonstrated understanding of risks to CROs’ businesses and how they might be impacted by Allergan.
· Advanced computer skills (word processing, spreadsheets, graphics, PowerPoint).
· Ability to travel (domestic and international) on short notice, up to 20%
· Strong financial business acumen and analytical skills
· Cross Cultural sensitivity
Proficiency in:
· Cross Functional Relationships
· Communication Skills
· Strategic Decision Making
· Execution/Results/Process Improvement
· Customer Satisfaction
· People and Talent Management
· Facilitating Change
· Financial/Budget Management
· Organization & Industry Awareness
· Influencing & Team Leadership
· Managing Conflict
· Negotiation
· Planning/Organization/Project Management
· Results Orientation
· Ability to Meet Challenging Milestones
· Ability to problem solve independently & with others
Preferred Skills/Qualification
· An MBA or MPH is highly desirable.
· Therapeutic Area experience strongly preferred
Education
· BS degree with 13 years of experience, MS degree with 11 years of experience, Ph.D. degree with 8 years of experience
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