Shalabh Singhal Email & Phone Number

Gaithersburg, Md, Us

Lawrence Township, Nj, Us

Led a large multidisciplinary matrix based program (comprised of clinical, manufacturing, non-clinical, clinical pharmacology, operations, medical affairs, commercial, regulatory, translational medicine, data scientists) to craft and execute all aspects of drug development across 9+ indications across different therapeutic areas.Directly accountable to the senior most leaders of the company for all aspects of the strategy and execution ranging from Pre-clinical through phase 3 and beyond. Inclusive of non-registrational data strategies and life cycle management programs for a combined budget of over $700MResponsibilities included (but not limited to) crafting asset strategies, managing budgets, ensuring timely execution with high quality and compliance, overseeing protocol development and trial operations, investor relations, business development, Identifying program/trial risks and creating mitigations while creating an inclusive, diverse and vibrant team culture.

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Clinical Development Team lead tasked with designing and executing the development programs and trials for systemic lupus, lupus nephritis, Sjogrens syndrome, Cutaneous lupusStudy Director and Clinical lead of Global Phase 2 studies for Lupus and lupus nephritis in which I was responsible for managing broad teams across different business models from fully outsourced to in-house managed studies. Designed and implemented the development programs from preclinical experiments through registration studies and beyond for Lupus, Lupus Nephritis and Sjogrens syndrome.Led the clinical portions of several IND filings for several therapeutic areas, several briefing books (FDA and EMA) for biologics and small molecules, across 3 regulatory divisions at the FDA and wrote several global health authority responses for several early and late stage clinical assets in different therapeutic areas. Designed and executed several first in human trials with strategies to take these assets through later stages of developmentDirectly supervise several (physicians and PhDs) members of the clinical team. Mentor other physicians and new members to the team

Lawrence Township, Nj, Us

Leader of the global cardiovascular medical matrix team that ensured appropriate dissemination of the company priorities in CV drug development. Ensured appropriate external input was being obtained in a timely and efficient manner Worked with the matrix team in developing and evaluating portfolio-wide strategies for creating development alliances and divestment as needed to serve our portfolio needsLed the ISR review process and non registrational data generation strategies for several assets. Also created novel ways to engage external thought leadersPartnered with Clinical, access and regulatory to engage the FDA, EMA and early discussion with HTA bodies such as NICE, HAS and GBA at the pre-phase 3 stageLeading the advocacy, IME, field medical, publication planning and execution, trial enrolment and thought leader engagement plans along with the publication strategy, writing and execution of several manuscripts for all our assets

Lawrence Township, Nj, Us

Part of the US medical affairs launch team for ApixabanLed the strategy for real world data generation and participated in life cycle management and phase 4 clinical trials strategy for apixaban in partmership with commercial and the health economics team and PfizerPart of the data generation planning and independent scientific research grant review

Provide Clinical care to patients in an ambulatory and hospital setting.

Indianapolis, In, Us

Provided Clinical care to patients in an ambulatory and hospital setting. Also had some administrative responsibilities in the daily management of our practice and of the hospitals I provided services at. Was nominated as one of the best doctors in Indianapolis in 2012 by Indianapolis monthly magazine.

Franklin, Indiana, Us

Bachelor Of Science, Chemistry

Doctor Of Medicine (M.D.), Medicine

Internal Medicine Residency Program

Cardiovascular Disease Fellowship Program