Sunitha Rangaraju, Ph.D. Email & Phone Number

Boston, MA, US

Cambridge, Massachusetts, US

• Director-level MSL collaborations include Medical Insights-driven strategy development & execution, moderating 5+ advisory boards and debriefings to Executive Team with recommendations, KOL engagements with senior.
• Accomplishments recognized by Blueprint Executive Leadership with "Sapphire Club" Award, MSL Team-voted ‘Sherlock Holmes’ Award, 20+ Spot Awards, and 50+ Bravo Awards from cross-functional collaborators in launch.

Cambridge, Massachusetts, US

• Engages in high-impact Medical Scientific engagements with Oncology KOLs/HCPs/APPs towards developing precision targeted therapies in NSCLC (EGFR & RET), Gastrointestinal Cancers (RET), Gastrointestinal Stromal Tumors.
• Partnered as a Medical Affairs team member during 5 successful product/indication launches for Pralsetinib and Avapritinib. Built, strengthened and deepened scientific KOL relationships by thoughtful scientific.
• Actionable Insights identified as Congress Lead and Insights Lead from KOLs/Congresses shared as recommendations to launch teams and incorporated in data-driven educational efforts. Data gaps and evidence generation.

Brussels, BE

• Developed collaborative working relationships with Neurology KOLs and strategies for patient value-based discussions on scientific/clinical/medical advancements in FDA-approved products (Vimpat, Briviact and Nayzilam).
• Was selected and served as US MSL Lead for pre-launch/launch medical activities for Nayzilam (Orphan designation; FDA approved in May 2019); provided clinical value-based insights/input on slide decks, FAQs, SRLs.
• Facilitated Medical Affairs activities, Phase I-III studies, Phase IV post-marketing studies, real-world evidence studies, investigator-initiated studies, and disease state education; completed Mini-Fellowship on UCB’s.
• Cross-functionally collaborated with Medical, Clinical, Commercial, Managed Markets, HEOR, Population Health, Internal Engine, and Patient Advocacy Groups towards driving patient value-based projects in New England.
• Engaged in patient value-based and data-driven discussions with formulary decision makers, market access/managed markets, and payers towards access for FDA-approved medicines (Vimpat, Briviact and Nayzilam).
• Engaged KOLs and allied healthcare professionals towards business partnership opportunities in New England ecosystem for innovative patient impact solutions.

• Developed collaborative working relationships with KOLs and compliant KOL engagement strategies to educate and raise awareness on CNS-active targeted therapy, Entrectinib (Rozlytrek) for solid tumors (including.
• Worked with clinical trial sites to implement next-generation sequencing assays/strategies towards identifying and enrolling ROS1+ and NTRK+ rare solid tumor patient population in basket trials for 2 NDA filings for.
• Engaged KOLs and presented latest clinical data at 3 national and 3 international scientific/clinical conferences; wrote 2 abstracts, collaborated with 20+ KOLs along with internal medical, regulatory, and legal teams.
• Collaborated with internal teams and global firms to drive cross-functional projects (pre-launch): publication planning with KOLs (3 published), 3 advisory boards (KOLs, slide reviews, topline findings to Executive.
• Served as the Neuro-Oncology, NSCLC and Thyroid Cancer subject matter expert to train newer MSLs and data dissemination on current literature in the Global Medical Affairs team (3 field slide deck preparations, 3 KOL.

Jacksonville Beach, Florida, US

• Comprehended pharmaceutical/biotechnology/medical device/medical education clients' project needs, established a rapport and offered medical communication solutions through team of writers and content developers.
• Performed business development, market assessment, market segmentation, branding, marketing, sales, sales forecasting and customer relationship management.
• Liaised between clients and leadership team to add value to both sides; developed connections, represent company at healthcare meetings in Boston area and interact with key opinion leaders.

La Jolla, California, US

• Collaborated with GNF (Novartis) to lead a project as Principal Investigator; designed and performed preclinical trials in a neuromuscular disease (ALS) with survival primary endpoint and neuropathological secondary.
• Developed innovative assays and therapeutic intervention strategies for neurological, psychiatric diseases, resulting in 5 publications with 2 MD Physicians.
• Contributed to clinical blood biomarker discovery by generating genomics data to compare between model organism and patients with psychiatric diseases.
• Presented results on ALS study at the World Preclinical Congress in Boston; received best presentation award for preclinical research presentation to clinical and pharmaceutical audience.

La Jolla, California, US

• Critically analyzed the next-generation sequencing cancer diagnostics market for NGPx product launch, in a team, and evaluated client company’s product, product differentiation, market share, cost-benefit analysis of.
• Received personal letter of appreciation from the CEO for the detailed analysis, oral presentation with recommendations and final written report.
• Won team award in the competition held by L.E.K. consulting company to analyze the market, product differentiation, competition and regulations for smart pill technology in personalized medicine.

La Jolla, California, US

• Performed business development activities, served as client support, drafted contracts/term sheets, and negotiated value-based higher royalty rates based on market analysis, resulting in higher revenue.
• Prepared and presented business and strategy recommendations based on market research, competitive analysis and clinical/regulatory landscape; won best team presentation award for SWOT analysis of wireless technology.
• Formulated questions and moderated conference calls with venture capitalists, company founders and the office about start-up companies; synthesized the information into meaningful case studies.
• Assisted with ongoing business deals, marketing strategy documents, and strategic alliances/collaborative partnerships with biotech industry, by performing due-diligence, and compiling critical deliverables/therapeutic.
• Mentored 40 students on start up technology validation, company formation, and venture creation in case study format in the Business of Biotechnology graduate class, taught by the Vice President of the Office of.
• Mastered the ability to adapt and communicate with a variety of biotech professionals outside of bench research, yet critically involved in the product development process, through weekly meetings, patent disclosures.

La Jolla, California, US

• Successfully performed drug screening and target validation for age-related neurodegenerative diseases.
• Conceived ideas, developed and performed troubleshooting of high-throughput assays as well as screened and validated small molecules using assays against disease markers.
• Managed and executed research projects by successfully writing and obtaining postdoctoral fellowship/grant from the muscular dystrophy association (MDA), revenue of $180,000 to the laboratory.
• Successfully developed miniaturized high-throughput assays, identified a promising drug candidate and tested in a preclinical trial using a mouse disease model.
• Collaborated and published manuscripts on high-throughput screening, assay development, high-content imaging in imaging platforms, in a crossfunctional team setting.
• Received best presentation awards for research presentations and travel award for written proposal.

• Completed coursework on regulatory affairs; attended workshops on FDA regulatory submissions and approvals, GxPs, CLIA/CAP regulations, OIG and ICH guidelines, post-drug approval submissions and compliance, adverse.
• Wrote newsletter article about regulatory affairs in simple layman terms on topics including FDA document preparation, submission and project management in regulatory filing.
• Followed the “What is new at the FDA” column to keep up-to-date on FDA regulations and newly approved products.
• Received formal mentoring and training on regulatory affairs and medical affairs topics by key opinion leaders from FDA and pharmaceutical industry.

• Organized industry bridge program visits to biotech/pharma companies in San Diego through establishing relationships and networks.
• Served as a liaison between the companies, organizers and fellows, conducted participant surveys and compiled the feedback into meaningful document for implementing improvement.
• Co-managed a budget of $20,000 to organize ‘Lightning talks’ research symposium, career development seminars and workshop events for TSRI postdocs.
• Served as a judge and critically evaluated 30 grant proposals and 24 ‘Lightning talk’ presentations for scientific merit, to confer the society’s prestigious awards.
• Helped organize the vendor show event in a team and provided live customer support for two consecutive years to generate revenue for the organization’s professional development activities.
• Sharpened practical experiences in leadership, team work and communication with professionals and peers of global diversity.

Gainesville, Florida, US

• Identified key drug pathways for demyelinating neurological disease resulting in disease-relevant publications.
• Received outstanding poster award for oral presentation and Bryan Robinson Grant-in-Aid endowment award for grant proposal.

Gainesville, Florida, US

• Identified protein degradation and protein homeostasis pathways of therapeutic potential in aging and disease in glia and neurons during demyelination.
• Conceived and tested drug targets and pathways resulting in 5-first-author articles.
• Received Grinter fellowship, Neuromuscular Plasticity award for outstanding poster, travel grants for presentation at conferences, American Society for Neurochemistry Young Investigator Educational Enhancement (YIEE).
• Offered advice and functioned as the founding Secretary and Advisory Council Member, North Central Florida Chapter of Society for Neuroscience (SfN); Grass traveling scientist program organizing committee member.
• Mentored 7 undergraduate students and served as discussion leader in graduate courses.
• Presented research at international conferences and ad-hoc reviewer for scientific research papers, invited speaker in multi-institutional talks.

IN

Phd, Neuroscience, Biomedical Science

Bachelors, Industrial Biotechnology