Vinod Kumar

Project Management Professional with ~ 17 years of experience in managing early and late-stage drug development assets; Development of [Small molecules - NCEs (New Chemical Entities), Large molecules - NBEs (New Biologic Entities), Biosimilars and NDDS - Novel Drug Delivery Systems (505 B2 differentiated products) across multicultural teams across the globe.

Planning, Monitoring and Tracking: Developed Integrated product development plans for assigned programs from scratch to commercial launch [Ideation> Lead selection> Preclinical development (Efficacy, Tox, Safety Pharmacology) > Clinical development > regulatory filings (IND, CTA, NDA, ANDA, BLA etc..) to licensing] across different therapeutic areas. Contributed to overall product strategy including life cycle management. Facilitated discussions to develop scope and objectives for potential product opportunities in a single document (Development of 1, 5, 30 pager Integrated product development plan). Responsible to guide project teams to proactively anticipate challenges and assess risks, define solutions and prepare contingency or mitigation plans. Responsible for working with the CFT teams and defining decision algorithms with clear go/no-go criteria for Stage Gate Reviews for each phase of development of the program.

Documenting and Reporting: Document key team information, decisions, actions, modifications to scope, resources, timelines, milestones and lesson learned to ensure project management systems are up to date. Responsible for providing bird's eye view of the on-going status of the projects and portfolio to the management in the form of interactive dashboard and portfolio reports via various project governance meetings. provide inputs to senior management for monthly and quarterly reports to investors. Assist Program Team Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations and other appropriate meetings

Budgeting: Responsible for facilitating drafting of organizational budget: Collaboration budget, R & D Budget, Clinical Trial Budget etc. Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities. Ensure detail on investments to be made across the portfolio and resources needed (both budget and headcount/FTEs).

Communication management and Governance: Setup project governance and communicate program progress and key risks/ issues to senior management. Via different forums across the organization. Develop and implement communication tools that enhance information exchange and stimulate creative project interactions. (MS project online, Interactive Power BI dashboards) for effective decision making at the organization level. Trouble shooting and facilitating project discussions b/w cross-functional teams in the R & D across all functions (In vitro, In vivo, NCE & Process chemistry labs, Upstream, Downstream, MSAT, Manufacturing, Analytical, Formulation, Molecular modeling, IPM, QA, Regulatory and Clinical) for milestone planning, tracking and ensuring that the projects are completed on time.

Global CRO management for outsourcing studies: [Pre-clinical (exploratory PK, invitro and in-vivo Pharmacology safety & efficacy studies, IND-NDA enabling tox studies), CMC small molecules (N-2, non-GMP Intermediate manufacturing, cGMP API and Drug Product manufacturing), CMC large molecules (Tech Transfer via MSAT, commercial manufacturing), Regulatory Submission and Consultation (regulated, semi-regulated markets), Business Development (business case analysis, Interaction with KOLs to get inputs for assessing the viability of the products), Clinical (Outsourced and program managed smaller Phase 1 to larger pivotal Phase 3 global trials in oncology, respiratory, dermatology, pain and inflammation)] as and when required for supporting the drug development, during lifecycle management of projects. Have managed several CDMO projects for custom synthesis API, N-2 intermediates across global CMO, to support drug development projects

As a regulatory program manager have facilitated drafting of meetings packages for the US FDA; Pre-IND, IND, EOPh2, pre-NDA, NDA submission for the US market, scientific advice meetings, CTA submission in the EU (BfArM - Germany, MHRA - UK, MPA - Sweden, MEB - The Netherlands)

Training and Team Development: Responsible for training team members on best practices, ensuring best practices are cross pollinated across teams

Organizational initiatives: Includes setting up of processes for drafting decision algorithms, SOPs and refining workflows across Projects, departments/SBUs for effective use of resources.

Facilitate Internal Audits via external auditors (across different locations, different functions in the R & D; for monitoring compliance, identification and documentation of gaps/issues, monitoring and tracking them until closure)

Identify gaps, thrive continuously to improve existing processes year on year, to ensure timely deliverables as per the organizational and departmental goals for sustainable business continuity. Strategic Senior Director known for high productivity and efficient task completion. Specialize in leadership development, operational strategy, and financial acumen. Excel in communication, problem-solving, and adaptability, ensuring seamless project execution and team synergy. Seasoned Senior Director with significant experience in managing large teams and developing effective strategies. Strengths include strategic leadership, vision-driven change management, and robust business acumen. Achievements include driving operational efficiency and fostering cross-departmental collaboration within previous organizations. Adept at directing infrastructure development and integration as a key leader. Talented communicator with a persuasive style and results-driven approach.

• Executive General Management Program, IIM Bangalore: 2022-2023
• Master of Pharmacy: Pharmacology; 2005-2007 Rajiv Gandhi University of Health Sciences- Bangalore
• Design Thinking: The Painted Sky; 2020
• Registered Pharmacist: Karnataka State Pharmacy Council - India, license no: 35547
• PMP Formal Training - Simplilearn, Proventures Education and Consulting

English, Hindi, Kannada

Painting, Cartooning, Table Tennis, Social Service

Secured 16th rank in the PGET Entrance test (2005) conducted by the Rajiv Gandhi University of Health Sciences, Karnataka, India; as pre-requisite for admission to Master of Pharmacy

Metabolic (Diabetes, Obesity), Oncology (MBC, AML, CML), Dermatology (AD, Psoriasis, Rosacea), CNS, Pain and Inflammation, CVS, Respiratory (Asthma & COPD), Ophthalmology, Bispecific Antibodies targeting oncology targets, Immuno- inflammatory diseases such as Crohn's, Inflammatory bowel disease

Topical, Oral, Injectable (nano-suspension, liposomal depot, gel), Medical Devices (DPI, MDI, PFS, Auto injectors)

• Valid India passport: Z5889487, Expiry: Feb 2030;
• Valid US H1B1 visa: M4485063, Multiple Entry, until Jul 2027