Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
PRIMARY JOB FUNCTION:
This position manages and directs the Clinical Research organization, encompassing Clinical Science, Biostatistics, Clinical Safety, Clinical Quality, and Clinical Project Management in all activities associated with strategy, development and execution of clinical studies for all AMO products. This position is responsible for the assessment of safety of all AMO products and all clinical-related activities necessary for submission for global registrations and commercialization of all AMO products. Assures the long-term effectiveness of the organization and ensures that the needs of the division with respect to Clinical Research are met. Establishes long-range plans and goals/functions and is responsible for the implementation and maintenance of the clinical research-related policies, processes and procedures related to their respective functional areas. Manages and develops people within the department to assure a well-trained, high quality team and appropriate succession to higher levels of management.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Responsible for ensuring compliance with applicable Governmental, Regulatory, Corporate and Divisional policies and procedures.
Direct the global vision and strategy for Clinical Research infrastructure and team development along with the planning and execution of clinical trials, systems, reports and submissions. Direct team to ensure that clinical studies of products satisfy medical need and/or commercial potential. Take the lead role in the development of the clinical strategy and design by defining the clinical plan and establishing the appropriate clinical protocol for the desired product claim. Establish and maintain appropriate systems to ensure adherence to ICH/GCP guidelines including training and successful results from independent audits. Select and interact with clinical sites. Manage all activities including collection and summary of data and ensure compliance. Generate clinically/scientifically sound statistically analyzed data to confirm performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements.
Review the clinical studies sections for regulatory submissions to ensure adequacy of support for all claims pertaining to safety, efficacy, clinical performance and Independent Review Board. Prepare quality regulatory submissions for U.S. and non-U.S. regulatory agencies. Provide compliance guidance on the conduct of clinical research division-wide, for developing and overseeing a quality training program and for compliance in all audits of the Clinical Research organization. Represent the Division's clinical research programs and results at FDA Divisional meetings, FDA Advisory Committee meetings and in discussions with senior management and trade meetings. Provide clinical input and consultation to project teams, R&D, Quality Assurance, and Regulatory Affairs.
POSITION ACCOUNTABILITY / SCOPE:
Accountable for achievement of both performance and financial goals for overall area of responsibility. Responsible for having superior leadership and coaching skills to build relationships throughout the Division (particularly with R&D, QA and RA) and motivate the Clinical Research team. Strong relationship building and matrix management, strong team work and strong communication skills. Guides, directs and serves as a role model for the organization, coaches staff and establishes succession plans for key positions. Review and monitor all budget areas. Determine and approve actions to deal with variances to meet the overall needs of the Clinical Research Organization and the Division. Accountable for interactions with FDA or other regulatory agencies regarding clinical research issues. Ensures goals are aligned with long term needs of the division. Aligns functional goals with long range business needs and strategies. Responsible for continuous improvement initiatives and leverages new appropriate technology consistent with regulatory and compliance strategies; assures appropriate training and education programs are in place.
Tracks appropriate metrics to ensure the effectiveness of these programs. Maintains, promotes and models social, ethical and organizational norms and adherence of the Clinical Research Organization to code of compliance conduct and ethical principles. Responsible for making timely decisions which reflect a consideration of the facts and data at hand which are in alignment with overall Division's goals.
15 years experience in the conduct of clinical studies to support new product development with increasing levels of responsibility. Ophthalmic medical device experience preferred.
Demonstrated success in developing and bringing new products to market.
Candidates must possess skills that span both science and business and have a thorough understanding of the scientific method and statistical analyses as they apply to the design and execution of adequate and well-controlled evaluations of new products. The experience stated above must be in the field of ophthalmology with high level of expertise in the areas of statistics, study design, ocular and systemic pathology, ocular and systemic pharmacology and ophthalmic optics. Additionally, must have strong supervisorial skills and ability to interact with all levels of the organization. Also, be able to interact with physicians at a peer level
Excellent written and communication skills.
Polished presentation skills are important as this position may be asked to represent the company to various regulatory agencies.
BS in Life/Physical Sciences or equivalent years of work experience required. Advanced degree in Life Sciences (MS/Ph.D.) or professional degree in healthcare-related field (MD, OD, PharmD) preferred.
Significant Work Activities and Conditions:
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Primary Location: USA-California-Santa Ana
Travel: Yes, 25 % of the Time
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