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Accomplished pharmaceutical leader with extensive industry, clinical development, alliance management and project management experience leading global, multi-disciplinary programs/teams and functional organizations with a proven track record for delivering results spanning pre-clinical through regulatory submission and life cycle management in multiple therapeutic areas and indications. Exceptional communication and negotiation skills and engaging interpersonal style fosters collaboration and development of excellent working relationships with alliance partners, program management personnel, global teams, opinion leaders and senior management. Demonstrated strategic, technical and operational leadership and problem solving in global matrix organizations, leading complex development and identification and resolution of risks. Strong ability to network, interface, influence and partner at all organizational levels. Skilled at absorbing and simplifying a range of complex information to develop and effectively communicate strategy and execute operational plans to achieve portfolio and business goals. Energetic and enthusiastic mentor who fosters a culture of quality, innovation, continuous improvement and commitment. Specialties: Alliance Management, Strategic partnerships,Drug and biologic compound research and development; Portfolio and Program Management; Clinical programs and development; Transformational initiatives and Six Sigma; Due Diligence; Leading global cross-functional programs and teams; Building and strengthening customer relationships; Regulatory Affairs and Submissions; CM&C (small molecules and biologics); Pharmacology; Biosimilar development and registration; CROs.
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Senior Director Strategic OperationsIqvia Jan 2023 - PresentDurham, North Carolina, UsSenior Director Strategic Operations and Partnership Account Lead, Large Pharma Account -
Director, Clinical Project ManagementIqvia Oct 2014 - Mar 2023Durham, North Carolina, Us- Program Director for mega cardiovascular outcomes trial overseeing project delivery and development of large study team and project management staff. - Leads Joint Operations Committee, Quality Council, and Finance meetings with customer. Facilitates Executive Steering Committee meetings. - Manages overall scope of work, objectives, quality of deliverables, and other program and study management activities for partner client’s portfolio of assets. Continually reviews and ensures adequate resourcing of all studies. - Serves as primary portfolio contact with sponsor to ensure appropriate communication channels are maintained and deliverables are met. Leads monthly portfolio governance meetings. - Ensures development of project plans for all phases of project lifecycle, including quality and risk management. Ensures issue escalation and resolution are clear and timely. - Develops, leads and implements continuous improvement for portfolio programs, studies and partnership. - Provides consultation to client on drug development process, study management strategy, and plans.
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Founder/PresidentMolecules To Market, Llc Aug 2013 - Oct 2014Molecules to Market helps clients deliver their innovative small molecules, biologics, mABs, and biosimilars to market faster. • Provided on-site program leadership for client’s initial US biosimilar submission, identified and mitigated approval risks and achieved aggressive cross-functional timeline and regulatory dates.• Worked directly with executive leadership to develop regulatory strategy, translated strategy into tactical plans and prepared materials for FDA and key opinion leader interactions.• Developed, implemented and optimized global biosimilar development process and accelerated timelines for other assets.• Served as biosimilar SME and developed business processes, program and functional dashboards, SharePoint architecture, tools and training.
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Director/Advisor, Project Management Office (Pmo)Eli Lilly And Company Jul 2009 - Jun 2010Indianapolis, Indiana, Us• Developed and implemented business processes and tools that drove efficiency across the portfolio and reduced cycle time.• Managed global Personalized Medicine governance committee, including prioritization and financial oversight of projects to help bring the highest value to the organization within budget and resource constraints.• Utilized strong commercial and GOER understanding to train research and marketing personnel on commercial label development and implementation.• Change agent driving Six Sigma and LEAN process improvement initiatives within PM and cross-functionally. -
Director/Platform Leader, Pharmaceutical Projects ManagementEli Lilly And Company Mar 2008 - Jun 2009Indianapolis, Indiana, Us• Provided strategic, operational, and technical leadership to a multi-geography (US, EU, Singapore) research and marketing team for a portfolio of molecules in clinical development and discovery in a new neuroscience indication. Coached and inspired project managers supporting individual molecules and senior level professionals from multiple functional and geographic areas. Utilized advanced analytic tools to manage and monitor progress of key metrics and KPIs.• Fostered teamwork and motivated team members to analyze and address complex technical, clinical and operational issues to deliver an unprecedented four milestones (two First Efficacy Doses (FED), two First Human Doses (FHD)) with limited resources.• Demonstrated strong financial acumen, effectively budgeting, forecasting, and managing resources to deliver results. Successfully evaluated probability and impact of risk, developed and implemented risk management plans for minimizing impact on objectives.• Performed international Due Diligence assessments on potential in-license molecules, including Japan. Met with each company, reviewed scientific data packages and commercial opportunities, and created development plans including resources and budget.• Established and fostered collaborative relationships with key industry, government and academic opinion leaders. Represented company at scientific, key opinion leader and payer meetings in the US, Canada and Europe.
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Director/Advisor, Pharmaceutical Projects ManagementEli Lilly And Company Oct 2000 - Feb 2008Indianapolis, Indiana, Us• Successfully led global, cross-functional teams in multiple therapeutic areas spanning the drug development process and reliably delivered programs on or ahead of time, in scope and within budget including: 2 Registration Decisions, 2 PoC decisions, 6 FEDs, 10 FHDs, and 15 Candidate Selections, while addressing technical issues and clinical holds.• Member of Neuroscience TA leadership team, responsible for translating strategy into operational plans and managing program execution. Effectively partnered with senior scientists and clinicians to achieve TA mission and strategy.• Created and led monthly shared learning forum for all program managers. Actively involved in program manager recruitment, interviewing and hiring. Trained and mentored Japan program managers.• Demonstrated strong negotiation, partnering and conflict resolution skills, effectively communicating with individuals and groups at all levels, bringing divergent opinions to consensus and driving decisions in a matrix organization.• Prepared regulatory documents and successfully interacted with FDA and OUS Regulators for pre-IND, IND Safety, clinical hold, scientific advice and End of Phase 2 meetings, demonstrating ICH, GCP and GMP knowledge.
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Director/Manager, Chemistry Manufacturing & Control Program ManagementEli Lilly And Company Jun 1996 - Sep 2000Indianapolis, Indiana, Us• Proven leadership of NDA/CTD submissions. Oversaw successful CM&C development of all products in TA unit’s portfolio. Led strategic and business planning process for business unit, managed progress of TA metrics and KPIs.• Directly managed and developed five CM&C program managers. Analyzed and assigned projects and distributed tasks. Led by example, developing and implementing quality and risk management plans, managed project budgets towards expected profitability, and actively managed timelines and communicated deliverables effectively with teams and senior management. All project milestones were delivered on time and within budget. Implemented robust development plans, resulting in promotion of two program managers.• Effectively led international co-licensing development process for a novel oral, rapid-disintegrating tablet formulation, resulting in first review cycle approval. Served as Alliance Manager, utilizing strong interpersonal skills to understand each company’s culture and capabilities, resulting in a more effective and efficient program team. Presented program and registration plan to EU Rapporteur for scientific advice. Effectively led team to resolve complex issues, resulting in successful launch and life cycle management of blockbuster molecule.
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Manager, Dry Products Manufacturing Qc, Packaging Qc, Qc LaboratoryEli Lilly And Company Jan 1992 - May 1996Indianapolis, Indiana, Us• Managed 60 personnel across three plant sites in Indianapolis, responsible for daily support of manufacturing, packaging, and laboratory testing. Led supply chain compliance, resulting in first successful FDA inspection of all three facilities.• Successfully led and motivated departments to improve in all performance measures. Successfully developed and transferred personnel, resulting in increased employee satisfaction, enhanced department capabilities, and reduction in turnover (< 10%).• As QC head for Oral Pediatric product recall, led rapid set-up and operation of product inspection lines, trained and supervised QC staff, reported weekly progress to FDA compliance office, and led Puerto Rico plant compliance and inspection preparation, resulting in successful inspection and recommencement of product supply.
Linda Murray Skills
Linda Murray Education Details
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Purdue UniversityMechanical Engineering
Frequently Asked Questions about Linda Murray
What company does Linda Murray work for?
Linda Murray works for Iqvia
What is Linda Murray's role at the current company?
Linda Murray's current role is Senior Director Strategic Operations at IQVIA.
What is Linda Murray's email address?
Linda Murray's email address is li****@****les.com
What is Linda Murray's direct phone number?
Linda Murray's direct phone number is (919) 998*****
What schools did Linda Murray attend?
Linda Murray attended Purdue University.
What are some of Linda Murray's interests?
Linda Murray has interest in Science And Technology, Social Services, Children, Health.
What skills is Linda Murray known for?
Linda Murray has skills like Pharmaceutical Industry, Clinical Development, Project Management, Drug Development, Program Management, Leadership, Regulatory Affairs, Fda, Strategic Planning, Life Sciences, Strategy, Clinical Trials.
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