Rohit Singh Tonk

Global clinical study oversight: Provided clinical development leadership across three global oncology programs

• CARES-310 (Phase 3, hepatocellular carcinoma), RM-202 (Phase 2, adenoid cystic carcinoma), and ReFocus (Phase 1/2, cholangiocarcinoma and other solid tumors) - overseeing design, execution, and scientific oversight from protocol inception through regulatory submission. Medical monitoring & data review: Conducted medical and safety data review, eligibility assessments, adverse event review, and protocol deviation evaluations for Phase 2-3 oncology trials (including rare disease programs) alongside CRO and sponsor medical monitors; analyzed and presented clinical findings across the rivoceranib program to inform cross-functional decision-making. Regulatory submissions: Co-authored NDAs, protocols, and orphan drug designation applications during a pivotal period of company growth. Investigator & regulatory liaison: Led peer-to-peer interactions with investigators and served as primary point of contact for clinical issues between the study team, investigators, ethics committees, and regulatory authorities across all U. S. rivoceranib and camrelizumab programs. Cross-functional collaboration: Partnered with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, CROs, investigators, and KOLs to align protocol interpretation, trial conduct, and regulatory strategy.

Regulatory writing: Prepared and QC-reviewed clinical and regulatory documents, including Investigator Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs), ensuring ICH-GCP, FDA, and EMA compliance. Cross-functional collaboration: Interfaced with clinical, biostatistics, pharmacovigilance, and regulatory teams in recurring cross-functional meetings to compile and align scientific messaging across submission documents. Document management: Used Microsoft Office, Adobe Acrobat, Share Point, Veeva RIM, and End Note to manage document workflows and support literature review.

Launch strategy & management: Supported launch planning, clinical development, medical affairs, and project management for top pharmaceutical companies, collaborating with KOLs, SMEs, advocacy groups, and advisory boards on the launches of Nuedexta (ALS, MS, dementia, Parkinson’s disease, stroke) and Abilify MyCite (bipolar disorder, schizophrenia). Medical strategy & affairs: Authored and presented high-stakes advisory board and executive-level presentations, initiated patient advocacy programs, and contributed to HCP education, KOL materials, and congress training toolkits, ensuring compliance through MLR/PRC review. Pipeline strategy: Assessed 20+ pipeline assets for prioritization, incorporating unmet need and market analysis, scientific and clinical validation, regulatory and development risk, and commercial strategy.

Research & analysis: Authored an ICH-GCP compliant, IRB-approved protocol and conducted statistical analyses for a graduate thesis examining adverse events within a $1.3 billion EHR conversion and the efficacy of a medication error reduction initiative; worked with KOLs and SMEs to refine study design, validate medication histories, and adjudicate patient outcomes. Publication & award: Published findings on a pharmacy-led medication monitoring initiative that reduced medication errors and adverse events; received the 2015 "Partner in Excellence" Award from Harvard Medical School.

Clinical due diligence: Evaluated neurological and immunological therapeutics - analyzing drug properties, mechanisms, clinical trials, target product profiles (TPP), and market differentiation - engaging KOLs to synthesize insights for go-to-market recommendations.

Clinical strategy & program design: Developed research-based oncology, neurology, and psychiatry clinical algorithms to optimize patient intake, provider decision support, and specialty clinic workflows, using patient data review and statistical analysis.

Clinical practice: Delivered comprehensive care in a high-volume quaternary care center, assessing and managing acute oncology and emergency medicine cases.