Clinical Scientist - Elevar Therapeutics (via Clinical Pharma Services) - Remote
(2019-03)
- Global clinical study oversight: Provided clinical development leadership across three global oncology programs — CARES-310 (Phase 3, hepatocellular carcinoma; randomized, double-blind, international trial of 543 patients across 95 sites in 13 countries), RM-202 (Phase 2, adenoid cystic carcinoma), and ReFocus (Phase 1/2, cholangiocarcinoma and other solid tumors) — spanning design, execution, and scientific oversight from protocol inception through regulatory submission.
- Medical monitoring & data review: Participated in meetings regarding medical and safety data review, eligibility assessments, adverse event review, and protocol deviation evaluations for oncology trials (including rare disease programs) alongside CRO and sponsor medical monitors; analyzed and presented clinical findings across the rivoceranib program, translating complex datasets into actionable conclusions for cross-functional teams.
- Regulatory submissions: Co-authored NDAs, CSRs, 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, CROs, 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 within a lean, entrepreneurial biopharma environment.
Regulatory Medical Writer - Clinical Pharma Services - Remote
(2017-01 - 2019-03)
- Regulatory Writing: Prepared and QC-reviewed 21+ clinical and regulatory documents — 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) — in compliance with ICH-GCP, FDA, and EMA requirements, primarily across oncology programs.
- 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, SharePoint, Veeva RIM, and EndNote to manage document workflows and support literature review.
Senior Consultant, Medical Affairs & Clinical Development - Navigant Consulting - New York, NY
(2015-11 - 2016-12)
- 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.
Principal Investigator & Medication Reconciliation Physician - Harvard Medical School: Brigham & Women's Hospital - Boston, MA
(2015-05 - 2015-10)
- 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.
Project-Based Independent Consultant - McKinsey & Company - New York, NY
(2014-12 - 2015-01)
- 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.
Physician Consultant - PatientPal - Cambridge, MA
(2013-03 - 2015-04)
- 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.
Resident Physician - Cleveland Clinic - Akron General - Akron, OH
(2012-06 - 2013-02)
- Clinical practice: Delivered comprehensive care in a high-volume quaternary care center, assessing and managing acute oncology and emergency medicine cases.
