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Click here or scroll down to respond to this candidateCandidate's Name
Deerfield, Illinois Street Address , USA PHONE NUMBER AVAILABLE EMAIL AVAILABLE LINKEDIN LINK AVAILABLE (Candidate's Name LinkedIn)Highly analytical and results-driven compliance thought leader with global experience in cultivating ethical frameworks, ensuring adherence to compliance standards across Enterprise governance, GCP, Study management, Real World data and evidence governance, integrated risk management, assurance strategies & tactics, and enhancing corporate governance within the pharmaceutical industry.GOVERNANCE AND COMPLIANCE THOUGHT LEADERININTEGRITY & COMPLIANCE I QUALITY & CLINICAL OPERATIONS I INTERNAL AUDIT I ESG I HSE IExpertise in streamlining governance processes to enhance operational efficiency and reduce time-to-market for healthcare solutions. Proven success in pioneering compliance strategies serving as benchmarks across business units. Specialized in overall ESG strategies, GCP governance, compliance and assurance programs, risk management, team empowerment, and leadership development. Equipped with a strong foundation in scientific academia and extensive business and compliance expertise to drive high-tech business partnerships and stakeholder relationships. Proficient in engaging with health authorities for innovative and rare diseases. Demonstrated leadership in directing global compliance teams, fostering collaboration and continuous improvement. Adept at developing and implementing compliance programs, streamlining clinical operations, and medical governance. Astute at ensuring robust tracking of Corporate Integrity Agreement (CIA) deliverables to uphold adherence to the US compliance program.Areas of Expertise ESG Compliance Program Development QMS, GCP & Clinical Operations Enterprise & Financial Risk Management Team Training & Leadership Good Manufacturing Practices (GMP) Medical Governance Health Economics & Outcome Research Audit & Operational Risk Management Project Management Business & Ethics Third party risk management Strategic Business Partnerships Regulatory Agency Management Ethical Standards & Framework Corporate Governance Global commercialization Due Diligence operationSignature AccomplishmentsLeadership & Integration: Steered the seamless integration of Alcon and Avexis into Novartis Gene Therapies, receiving accolades for both projects and ensuring their successful incorporation into the broader Novartis framework.Business Growth: Drove substantial business growth as GM of Sri Lanka and Maldives operations while securing the cluster top performer award and consistently outperforming targets.Compliance Excellence: Achieved consecutive top performer awards in compliance, excelling as Compliance Head in Singapore and Compliance Director in Switzerland, recognized for outstanding adherence to regulatory standards.Impactful Leadership: Honored as the most impactful functional leader in Novartis Gene Therapies, celebrated for exceptional leadership and strategic vision in advancing the company's therapeutic initiatives.Professional ExperienceNovartis Gene Therapies (GTx), Bannockburn, ILExecutive Director, Chief Compliance Officer, GTx USADecember 2021 June 2024Lead the US ERC team to foster an environment of team collaboration and continuous improvement. Develop and implement ESG tactics and controls as part of overall culture development and nurturing initiative, innovative compliance programs to enhance business decision-making processes. Direct compliance and governance programs across Good Clinical Practice (GCP) governance, general compliance, enterprise risk management, and assurance exercises. Collaborate with internal audit teams to elevate risk management and ensure adherence to regulatory requirements.Implemented ESG strategies and tactics, aligning with the evolving regulatory landscape and reporting requirements.Bulit capabilities and skillsets of the team aligning with the evolving requirements of the eco-systems including good compliance program, ESG and end to end risk management.Streamlined clinical operations, Health Economics and Outcomes Research (HEOR) management, Real-World Evidence (RWE) platforms, and third-party governance on data management.Ensured robust tracking of Corporate Integrity Agreement (CIA) deliverables aligned with the US compliance program and defined a forward-looking governance path.Head, Ethics, Risk & Compliance, GTxDirected the GTx worldwide ERC team to foster skill development and build a high-performing and cohesive unit. Cultivated a highly motivated team through strategic coaching, development, and empowerment. Established forward-looking compliance programs to enable informed business decisions and prepare team members for future leadership roles. Oversaw and ensured adherence to compliance policies, procedures, systems, and transparency reporting.Spearheaded compliance initiatives to fortify business partnerships, enhance assurance programs, and optimize risk management.Developed a 360-degree and well-connected compliance and governance program across GCP governance, general compliance, enterprise risk management, and assurance exercises.Consistently evaluate overall culture generating programs consisting of ESG, Enterprise risk management, Corporate policies and standards and external benchmarking cum regulatory and reporting requirements.Resolved regulatory issues by collaborating with internal auditors and representing the organization to external auditors and regulatory officials.Novartis Pharma AG, Switzerland. February 2019 November 2021Business Franchise ERC DirectorAdvised the Global Marketing and Value Access team to optimize the delivery and implementation of global projects. Established clear governance pathways and standardized documentation to support initiatives, such as Implementation Science and partnerships with health authorities, including population health and entry agreements during registration. Collaborated with a high-performing team to simplify company standards and procedures, including managing Patient-Oriented Programs (POP), Market Research, and differentiating non-interventional studies across Health Economics and Outcome Research (HEOR).Refined regulatory processes by developing and implementing access models, including pre-approval paths.Steered the creation of cross-border treatment guidelines, Overall GCP governance for RWE and publication paths to enhance market research projects.Drove continuous improvement initiatives by coordinating with the internal audit team, leveraging technology, data analytics, machine learning, and digital approaches.Novartis Singapore PTE LTD, SingaporeHead of Compliance, Singapore & Asian Emerging MarketsJune 2015 January 2019Established and directed the compliance and risk team for Singapore and Asian emerging markets. Designed and implemented efficient compliance programs to fortify business partnerships, manage risks, and support the operational models of various business units.Developed assurance methodologies and promoted governance across markets by collaborating with Internal Audit team.Constructed governance and assurance models for diverse business units, including mass-market generics, innovative pharmaceuticals, and oncology products.Led GCP governance and study management for development and medical affair studies out of Singapore.Championed compliance with regulatory standards and optimized operational processes by overseeing distributor market governance frameworks.Novartis Pharma Services AG, Sri LankaCountry Manager, Sri Lanka and MaldivesSeptember 2012 May 2015Led all aspects of General Management while overseeing cross-functional teams and P&L accountability. Cultivated key leadership talent for self-pay and tender-driven markets to drive strategic initiatives, drive business growth, and optimize market penetration.Enhanced operational efficiency by streamlining processes and optimizing resource allocation.Drove revenue growth by conducting market analysis and implementing sales strategies.Novartis Pharma AG, SwitzerlandRegional Brand Lead, Ophthalmology & ALCON Integration ManagerAugust 2011 August 2012Served as the Ophthalmology Brand Lead for Asia Pacific, Australia, Middle East, and Africa. Developed and implemented commercial strategies and drove market growth. Led the seamless integration of Alcon into Novartis operations to foster regional alignment and transition.Streamlined brand management and accelerated market penetration by cultivating strong stakeholder relationships.Partnered with cross-functional teams to implement strategic initiatives and optimize brand performance.Novartis Asia Pacific, Singapore (Based out of Bangladesh)Cluster Brand LeadJanuary 2010 July 2011Managed a strategic brand within the Metabolic portfolio across nine markets in the Asia Pacific region while delivering leadership and support to in-country brand teams. Developed and implemented brand strategies to improve market positioning and messaging. Coordinated cross-functional efforts to align sales, marketing, and medical affairs following regional objectives.Drove regional success of the brand by fostering collaboration among sales, marketing, and medical affairs teams.Increased brand visibility and market share through strategic planning and execution.Additional ExperienceNovartis Bangladesh PVT LTD Head Business Franchise, Senior Portfolio Manager, Portfolio ManagerSquare Pharmaceuticals LTD, Bangladesh Senior Product Executive, Product Executive, SalesClinical and Retail Pharmacist Part-time involvement during final year masters in pharmacyMarket Research Field Agent Field work for a market research agency during hons in pharmacyExternal InvolvementSpeaker at Business & Compliance Forums & Conferences: Delivered presentations on topics, such as Artificial Intelligence (AI) and Generative Artificial Intelligence (GAI) in rare disease ecosystems, governance of Advanced Therapy Medicinal Products (ATMP) including gene and cell therapies, radio ligand therapies (RLT), and siRNA.Publication Contributor: Authored articles on the impact of AI and GAI in rare disease spaces and ATMP, contributing to the body of knowledge in advanced fields.EducationMaster of Science (MS) in Health AdministrationInstitute of Health Sciences, Colombo, Sri LankaMalaysia e-UniversityMaster in business administration (MBA) in MarketingUniversity of Dhaka, Dhaka, BangladeshMPharm (Masters in Pharmacy)University of Dhaka, Dhaka, BangladeshBPharm (Hons in Pharmacy)University of Dhaka, Dhaka, BangladeshProfessional DevelopmentBusiness Finance IIHarvard Business School, Boston MAPost-Graduation in Leadership CapabilityGlasgow Caledonian University, Glasgow, UKCertified Compliance OfficerEthics and Compliance Initiative (ECI), USA |
