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Director, Global Development Operations

Allergan, Inc.

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Location:
Irvine, CA
Posted Date:
3/18/2014
Position Type:
Full time
Job Code:
140250
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:

Job Description

About Allergan:

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential.  Today, we have 11,000+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

Location: Irvine, CA or Bridgewater, NJ

About the Position:

The Director, Global Development Operations, 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. Leads assigned clinical sub-teams to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Provides project and resource management across therapeutic area portfolio. Serve as a member of therapeutic area management team with focus on project and resource management for clinical projects and participates in therapeutic area teams to provide input to ensure studies are executable. Contributes to Global Development Operations strategic and operational development by active participation in the GDO executive leadership team.

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.

Principal Responsibilities:

Global Clinical Operations Lead
Works collaboratively with other Development Operations Leads to agree upon processes, systems and procedures to lead Global Development Operations. 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 Development Operations. 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.

Study Management
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 Global Development Operations Leads to ensure consistent processes are collectively agreed upon and followed by all Global Development Operations 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.

Leadership and People Development
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.

Budget Oversight
Assists in the development of operations budgets ensuring program needs are identified in budget. Ensures study budgets are managed without overages or discrepancies.

General Role
The incumbent 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

Preferred candidates will have:
Bachelors degree with experience in a relevant field: BS degree with 13 years of experience, MS degree with 11 years of experience, Ph.D degree with 8 years of experience
An MBA or MPH is highly desirable.
Therapeutic Area experience strongly preferred
Minimum 13 years of experience working in a clinical operations organization, preferably within pharma or CRO.
Minimum 13 years of experience working in clinical research with a strong understanding of the clinical and drug development process
Minimum 8 years of experience 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.
Competencies and essential skills in the following: Cross Functional Relationships, Communication, Strategic Decision Making, Execution/Results/Process Improvement, Customer Satisfaction, People and Talent Management, Facilitating Change, Financial/Budget Management, Organization & Industry Awareness, Influencing and Team Leadership, Managing Conflict, Negotiation, Planning/Organization/Project Management, Results Orientation, Ability to Meet Challenging Milestones, Ability to problem solve independently and with others
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

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