Full Time

3 - 5 years

MD

to 25%

· The DIRECTOR, PHARMACEUTICAL CLINICAL & SCIENTIFIC AFFAIRS is responsible for the development of products in the Rx, OTC, Generics and Nutraceuticals categories

· 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

· Accountable for product clinical development programs that are of high quality but also lead to timely and cost-effective regulatory approval

· Serves as the leader of the Pharmaceutical 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 Pharmaceutical business and more specific product clinical development plan

· Performs management functions 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

• Medical Degree from an accredited US or foreign medical school

• 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

Capabilities
·Demonstrated ability to work independently, initiative and strong work ethic
·Excellent planning and organizational skills
·Strong leadership experience and motivational skills
·Ability to influence internal and external stakeholders
·Excellent oral/written/presentation communications
·Ability to work on a matrixed and cross-functional environment
·Strong interpersonal skills
·Willing and able to travel