• Provide leadership, program direction and general oversight to the Office's operations and regulatory actions at Master Reviewer, Team Leader and Branch Chief capacities• Supervise a group of professional staff involved in the identification of issues, planning for and developing new programs and projects that affect the work and decisions within ONDP/OPQ/CDER and FDA• Solve unusual and often precedent-setting problems associated with the Branch's regulatory reviews activities• Provide advice and assessments concerning policy development and management strategies and plans to Division director• Develop new scientific initiatives and innovation opportunities to advance mission and vision of Division of Biopharmaceutics for 21st Century drug products• Implement cutting-edge biopharmaceutics concepts and principles to assure delivering quality products to the public• Inform staff of new scientific developments, laws, policies, and objectives that affect Division programs and activities• Streamline implementation of new laws and regulations that affect the mission of the Division and have the potential to impact changes in FDA guidance, processes, and procedures• Oversee the review of Investigative New Drug Applications (IND), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and/or their supplemental submissions and CDRH Consults• Recommend strategic direction for the initiation of MAPP, and SOP development and revision of existing documents and/or training/outreach materials• Identify additional resource needs to accomplish workloads and projects by implementing creative solutions to resource challenges and constraints

• Reviewed (primary and secondary) the human biopharmaceutics and pharmacokinetics portion of the New Drug Application (NDAs), Investigational Drug Applications (INDs) and Biological License Applications (BLAs) and provide input in drug approval process in the areas of Dermal, Dental, GI, Analgesics, Anti-inflammatory, Ophthalmic, and OTC Drug Products at senior Clinical Pharmacologist/Pharmacokineticist and Team Leader capacity• Evaluated and suggested dose and dosing regimen selection during drug development based on pre-clinical, clinical pharmacokinetics (Pop PK, Exposure-Response), clinical and other pre-IND activities• Reviewed Phase2/3 clinical studies in terms of appropriateness of the study designs and statistical methods to evaluate safety, efficacy, adverse drug reactions and risk assessment• Prepared materials for Clinical Pharmacology briefings and professional organization meetings.• Developed regulatory policies and guidances• Ensured that prescribing information regarding the use of prescription drugs is consistent across drug classes