Provides strategy, resourcing assignment, delivery, and oversight of clinical and operational aspects of clinical trials and drug development programs in the US and China in the following disease areas: HIV, HBV, COVID-19, and depression.Oversees clinical and operational planning and execution of clinical trials (e.g., vendor selection, contract negotiation, and trial management). Acting program lead of depression assets, overseeing cross-functional team; ensuring drug development meets milestones, timelines, and quality standards.Provides project team oversight on clinical trials by driving project goals in terms of scope, time, cost, and quality performance.Ensures successful management and coordination of efforts assigned to all members of global project teams, including but not limited to Regulatory, Clinical Operations, Biometrics, Clinical Research, and Safety to support milestone achievement and overall project/program delivery.Clinical lead in clinical strategy development, authoring, execution, and management of clinical trials and programs.Clinical lead; author of IND submissions, briefing documents, and written responses to regulatory authorities. Represents the sponsor company at FDA meetings. Completed one EUA by authoring and leading teams.Leads medical writing activities and the development and implementation of document strategy for clinical and regulatory documents, which includes direct authoring of clinical protocols, DSURs, investigator brochures, clinical study reports, and other study and asset level documents for US and China development programs.Develops SOPs, technical document templates (e.g., protocols, DSURs, Investigator Brochures, clinical study reports and associated appendices, and clinical CTDs), and working practices for clinical drug development.Trains and mentors clinical research, clinical operations, and medical writing employees on key aspects of clinical trial development, execution, and management.

Created and developed the US clinical operations department and clinical medical writing processes to meet the needs of an early-stage development company focused on infectious disease indications. Completed two US IND submissions for HIV and one China CDE IND submission for HBV by authoring and leading clinical teams in the generation of high-quality clinical CTDs, briefing documents, and written responses to regulatory authority questions.Developed and authored clinical protocols, investigator brochures, and other study and asset level documents for US and China asset development programs.Led clinical teams in the clinical strategy, authoring, execution, and management of US clinical trials. Trained and mentored clinical research and clinical operations employees on key aspects of clinical trial development, execution, and management.

Reporting directly to the CMO, led alignment and agreement on clinical operational strategies and plans for HBV product development with external pharma partners.Led multidisciplinary teams on the clinical strategy development and authoring of clinical protocols, investigator brochures, and other study and asset level documents to ensure high quality, timely, and cost-effective deliverables.Trained and mentored employees on key aspects of clinical trial development, execution, and management.

Led clinical teams in the clinical strategy, authoring, execution, and management of clinical trials and programs for respiratory clinical development (Trelegy, Breo, Anoro, Incruse, Advair, Vilanterol, and batefenterol [muscarinic beta2-agonist NCE]).Ensured timely and successful execution, clinical oversight, and completion of clinical trials (3 months to 3-year study durations) and multiple drug development programs by effectively leading, communicating, and collaborating with empowered teams.Ensured that clinical trial deliverables were accurate, consistent, on time, and within budget due to effective selection of CROs/vendors, set-up of study systems (e.g., EDC, IVRS/IWRS, and CTMS), and training of CRAs, Investigators, and site personnel.Assured high quality and robust drug development by leading teams in the development and authoring of phase 2 through 4 clinical trial documents (e.g., protocols; informed consents; study procedure manuals, clinical study reports), clinical sections of IND and CTA submissions, DSURs, and Investigator Brochures.Drove resolution of scientific issues by engaging and liaising with investigators and key opinion leaders regarding clinical program strategy and scientific advice.Successfully completed regulatory drug submissions by authoring and leading teams in the generation of high-quality NDA and MAA CTDs, providing written responses to regulatory authority questions, and representing the sponsor company at US and EU regulatory meetings. Made important contributions to medical literature by authoring and collaborating on external scientific communications.

Led teams in the clinical strategy, authoring, and execution and management of clinical trials and programs for respiratory clinical development (Breo, Advair, and batefenterol).Ensured timely and successful execution, clinical oversight, and completion of clinical trials (3 months to 3-year study durations) and multiple drug development programs by effectively leading, communicating, and collaborating with empowered teams.Ensured that clinical trial deliverables were accurate, consistent, on time, and within budget due to effective selection of CROs/vendors, set-up of study systems (e.g., EDC, IVRS/IWRS, and CTMS), and training of CRAs, Investigators, and site personnel.Assured high quality and robust drug development by leading teams in the development and authoring of phase 2 through 4 clinical trial documents (e.g., protocols; informed consents; study procedure manuals, clinical study reports), clinical sections of IND and CTA submissions, DSURs, and Investigator Brochures.Drove resolution of scientific issues by engaging and liaising with investigators and key opinion leaders regarding clinical program strategy and scientific advice.Successfully completed regulatory drug submissions (including the TORCH COPD mortality indication) by authoring and leading teams in the generation of high-quality NDA and MAA CTDs, providing written responses to regulatory authority questions, and Advisory Committee meeting preparations and representation. Contributed to innovative methods of drug development by leading teams tasked with assessing and developing novel efficacy endpoints for use in clinical trials and development programs (e.g., Shortness of Breath with Daily Activities Questionnaire development and validation; IOS and symptom assessments from the 3-year Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points [ECLIPSE] study). Made contributions to medical literature by authoring/collaborating on external scientific communications

Clinical study team leader and contributor of phase 3 and 4 trials supporting Advair Diskus (designed and implemented protocols, data review/interpretation, clinical study report author)Clinical lead and contributor on regulatory submissions (e.g., briefing documents, safety updates, sNDA CTD modules, and advisory committee meeting preparation)Author on scientific communications in support of Advair Diskus. Provided clinical support for NCEs which included an oral tachykinin-3 antagonist for COPD and a separate cough indication; oral and inhaled p38 MAP KINASE Inhibitors for COPD.Contributed to innovative methods of drug development by leading teams tasked with assessing and developing novel efficacy endpoints for use in clinical trials and development programs (e.g., Lifeshirt Cough monitor development and validation).