Director, Pediatric Product Development, Dublin, Gilead Sciences, Inc.

Director, Pediatric Product Development, Dublin, Gilead Sciences, Inc.

Details + Details -

  • Job type: Full time
  • Contract type: Permanent
  • Salary type: Monthly
  • Occupation: Director, pediatric product development

Location + Location -

  • Country: Ireland
  • Region: Dublin
  • City: Dublin
  • Address: Dublin

Description + Description -

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Responsibilities The Director of Pediatric Product Development will be responsible for leading and developing small molecule drug products intended for pediatrics. Represent CMC function on global pediatric team and contribute to development of clinical and regulatory strategy across pediatric portfolio. Responsible for authoring CMC sections of global pediatric plans Collaborates with external organizations to progress development of pediatric products Responsible for the design & development of products, development of control strategies for all small molecules intended for pediatric patients, application of new tools and technologies to enable advancement of pediatric assets. Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets. Implement differentiated and innovative strategies to deliver high-quality products and services to collaborators Provide guidance, as required, for pediatric drug product development teams Develop and maintain effective working relationships and communications within CMC, Clinical, Commercial, Regulatory, and other functional areas and other customer groups Ensure compliance with EHS regulations and company policies & procedures Demonstrated ability to develop and execute business strategy to bring maximum value to the organization Qualifications Degree in pharmaceutical sciences or related sciences; PhD with several years of experience, alternatively MS with significant years of experience or equivalent and a record of roles with increasing responsibility In-depth knowledge and understanding of drug product development including pediatric formulations and packaging, commercial technology transfer to manufacturing and packaging, CMC related FDA and international regulations Knowledge of pediatric regulations Previous success working effectively in a multidisciplinary, highly matrixed environment Excellent decision-making, written and verbal communication skills Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively Gilead or the Company ) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

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Presented By: Gilead Sciences, Inc.