Broad experience in developing business models with main focus on setting strategic CRO/CMO relationship and collaboration in Pharma industries. Diversified experience base spanning from drug discovery and development to global sourcing, supply chain management, and adapting to market dynamics. Areas of expertise include: Leadership and Mentoring Outsourcing, Collaboration Start Ups and vendor Management Business Development Process Development and Improvement Regulatory Compliance and Filings Project Management Leadership: Strategic thinker with excellent project management, interpersonal and business communication skills. Led 12 senior managers at Vendors and Pfizer fostering team approaches to maximize deliverables. Engage with senior management with focused approach and provide project matrix reports and recommendations. Outsourcing & Vendor Management: Successfully defined cost effective outsourcing models and implemented best business practices at Pfizer and strategic partners. Assess strategic vs. tactical sourcing needs. .Efforts in this area resulted in cost reduction of 35% and overall cycle time reduction of 32% at Pfizer and gain of more than $2MM in business revenue for Contract Manufacture Organization (CMO). Currently managing EPEM and IIR projects at Pfizer. Project Management and Team Building: Successful at the selection and start ups of three new CMO's, providing "on site" support to build the Pfizer-vendor relationships. Developed PM tools for planning, technical meetings, reporting, finance and matrix for productivity measurement. Cross functional engagement with partner lines to assemble operating plans. Prepare and review MSA, SOW and quality agreements. Business Development: Executive level experience at Jubilant and Calyx; both are India based CRO-CMOs, offering contract manufacturing and clinical services in North America. Evaluated and provided market trends and competitive intelligence to seek organic growth, resulting in new business with three major Pharma companies and the Clinton foundation for anti-malarial program. Contract preparation and negotiations.
Project LeaderJun 2011 - Current Almac / PfizerCenter Groton, CT
Established global network within Pharma and CRO/CMO's, staying current with the market trend; monitoring FTE vs.
FFS, and emerging new business models in the pharma industry.
Having worked on both sides of the field - receiving and supplying ends, I have developed unique skills that play a crucial role in bringing excellent business prospects to any company I serve.
Supply Chain Management of delivering Drugs used in Phase III-IV clinical trials in Brazil, Mexico, Thailand and South Korea.
Supply Chain Lead for IIR and collaborative IIR.
Negotiate contracts and develop supply strategies in collaboration with internal stakeholders.
Proficient at using Pfizer intra web systems like GDMS and Clinical Trail Master File.
Mapped the business process for executing and tracking key milestones enabling filing and launching of Established Products in EM countries.
Tracked project timelines and issued Quarterly Matrix reports to management.
Co-chair weekly meeting with Vendors, clinical ops team, supply chain line functions and regulatory affairs.
Subject Matter Expert (SME) at identifying and resolving issues to find path forward.
Develop risk mitigation strategy for the areas of high risks.
Participate in "Continuous Improvement" initiative in the relatively new EM business unit, seeking buy-ins from key stakeholders.
Project Manager for Pfizer Trial Master File (PTMF) implementation in PharmSci.
Led staff engaged in migrating over 100 studies from ELARA to PTMF, performing quarterly TMF-QC and developing trackers to support regulatory inspections.
Director of Business DevelopmentJan 2010 - May 2011 Jubilant ReseachBangalore, India
Contract Research Organization engaged in Oncology, CNS-Pain, and Inflammation and diabetes research.
located in the US) Developed business strategies to seek pharma and academic partners for integrated drug discovery collaborations, contract manufacture and accessing new technologies.
Secured collaborative research projects with two major pharma companies; total valued at over $2MM.
Expert at Value Generating Strategies - Time, Cost and Innovation.
Develop Fee for Service (FFS) and Full Time Equivalent (FTE) models to match the business opportunity.
Responsible for the preparation and review of CDA, MSA, RFP-RFI and other relevant business documents.
President, Business DevelopmentFeb 2007 - Dec 2009 Calyx Chemicals and Pharmaceuticals LtdMumbai, India
Pharmaceutical Companies engaged in manufacture of API & Established Products.
President of Business Development (BD) for API services, Located in the US.
Member of Corporate Senior Management Committee responsible for developing business strategies for organic growth, reporting to CEO.
Took this opportunity to gain experience from the Asian CMO perspectives.
Supervised 15 people in India-US offices and co-developed business plans with the President of research.
Held leadership position of increasing responsibilities for developing new client pools and optimized business processes (operational and regulatory) to improve competitiveness in the market.
Strong consultative and project management skills to interpret market research data (e.g.
IMS Health) and business conditions,.
Associate Research FellowJan 1985 - Jan 2007 Pfizer IncGroton, CT
Groton, Connecticut Pfizer Global Supplies and R&D Managed outsourced FTE resources and delivered -30% of research portfolio through outsourcing.
Responsible for managing annual budget of $8MM.
This had a significant impact on sustaining the growing portfolio in Pfizer Research; meeting the "Discovery to Phase I and II" site goals.
Effective communication, and people and project management skills.
Chaired technical and business meetings between Pfizer and vendors to ascertain that projects were on track and deliverables met.
Achieved 32% productivity improvement in 2002 (vs.
2001) at one of the preferred vendors in Europe.
Mentored scientists at Pfizer and vendors, training them to execute manufacture process under appropriate safety and quality assurance standards; e.g.
Tasocitinib (CP-690550) key intermediate used to prepare the first clinical lot.
Interfaced with sourcing, legal and procurement executing CDA, MSA and SOW.
Participated in Quarterly Steering Committee meeting between Pfizer and vendors for portfolio and business-spent reviews.
Provided (SME) guidance for evaluating low cost CROs in Asia.
Expert in auditing and approving new vendors.
Developed the matrix of efficiency/productivity vs.
spent at CMO, and KPI measurement for critical milestones.
Ph.D: Organic Chemistry1984 University of AkronOhio Organic Chemistry
M.S: Organic Chemistry / Pharmaceutical Chemistry1980 University of Bombay Organic Chemistry / Pharmaceutical Chemistry
B.S: Chemistry and Physics1978 University of Bombay Chemistry and Physics Recipient of Pfizer Global R&D award for leadership and achievement of delivering research portfolio in sustained manner
PGRD Project Team award for outstanding performance for vendor development, technology transfer and delivery of antibacterial candidates for tox and clinical trials, 2005.
*Chemical R&D, PGRD award for individual achievement for delivering antibacterial candidates to clinic in the shortest period of time - 7 months from nomination, 2004
*Early Candidate Management Team Award. Developed and executed successful operation plans to progress "Sleep Disorder" candidate for from Discovery to clinical trials, 2001.
Patents / Publications/References: Available upon request