http://bauschandlomb.jobs2web.com/go/Orange-County-CA-Engineer-Jobs/21578/ View Orange County, CA Engineer Jobs at Bausch and Lomb en-us http://basf.jobs2web.com/images/bauschandlomb/logo.gif http://bauschandlomb.jobs2web.com/go/Orange-County-CA-Engineer-Jobs/21578/ 720 Job Title:
Director, Clinical & Scientific Affairs

Req #:
5228BR

Job Description:
Position Summary The Surgical Director of Clinical & Scientific Affairs at Bausch & Lomb is responsible for the development of products in the Surgical medical device category. Leads a group of scientists (MDs and ODs) responsible for clinical trial design, scientific evaluations during the conduct of the trials (monitoring of safety, eligibility, enrollment, and data consistency), and analysis of results. Specific Job Duties . Accountable for product clinical development programs that are of high-quality, but that also lead to timely and cost-effective regulatory approval. . Serves as the leader of the Surgical Global Clinical Development matrixed team in the planning and executions of clinical trials. The team includes operations, statistics, data management, and medical writing, in addition to scientists. . Collaborates and takes clinical leadership role within cross-functional teams, including project managers, preclinical, regulatory, clinical trial materials, etc. . Responsible for the clinical aspects of clinical study reports and responses to regulatory authorities. . Contributes to abstract/manuscript/presentation writing/review, for scientific meetings and internal management reviews. . Maintains responsibility for the clinical input into Business Development due diligences. . Provides medical expertise and medical evaluation of questions regarding ophthalmology clinical practice. . Develops/Maintains relationships with external experts who might be needed to support clinical development programs. . Provides scientific and clinical research expertise in the development of overall strategy of the Surgical business and more specific product clinical development plan. . Performs management functions such as goal setting, individual development plans, and performance evaluations of staff. Identifies training needs to staff and implements training plan. . Proactively evaluates and contributes to process improvement. Management Competencies . Demonstrated knowledge and skill in submission strategies as well as overall Regulatory Science. . Demonstrated experience in leading a team and carrying out performance management and talent processes. . Ability to partner, negotiate, and drive towards win/win outcomes. . Develops effective global internal/external relationships (e.g. cross category, cross functional, etc.) . Excellent oral communication skills (command of English language) and technical writing skills. . Ability to effectively present information in one-on-one and small group situations to internal customers and other employees of the organization. Ability to communicate well with all levels of the organizations. Technical Competencies . Strong questioning and problem-solving skills. . Mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions. . Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures. . Ability to write routine reports and business correspondence. . Computer literate with general office software and internet use.

Qualifications
. Medical Degree (MD / OD) from an accredited US or foreign medical school preferred. PhD with ophthalmic clinical study experience. . At least 5 years of total experience, post-medical training, including clinical practice AND industry experience in the planning, execution, and reporting of clinical trials. . Strong understanding of GCP, ICH, and regulatory compliance. . Knowledge of scientific methods, research design, and medical practices and procedures in ophthalmology.

Work Location CA - Aliso Viejo Relocation Available Yes

Status Full-Time]]> http://bauschandlomb.jobs2web.com/job/ALISO-VIEJO-Director,-Clinical-&-Scientific-Affairs-Job-CA-92653/609162/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS http://bauschandlomb.jobs2web.com/job/ALISO-VIEJO-Director,-Clinical-&-Scientific-Affairs-Job-CA-92653/609162/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W_RSS