Stephen A Edwards's Location
Wendell, North Carolina, United States, United States
Stephen A Edwards's Contact Details
Stephen A Edwards work email
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Stephen A Edwards personal email
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About Stephen A Edwards
Accomplished, motivated pharmaceutical professional offering drug development experience that encompasses multiple disciplines (chemistry and manufacturing controls [CMC], Phase 1-3 clinical development, and project management) across multiple therapeutic areas. Recognized as leader with strong skill sets in driving delivery, prioritizing in a resource constrained environment, senior stakeholder management, risk management, and managing multiple projects within compressed time constraints.My key strengths are high learning agility, excellent communication and interpersonal skills, and a belief that excellence in project management enables organizations to deliver high quality results.Core Competences: • Drug Development, • Project Management, • Project Leadership, • Strategic Planning, • Problem Solving, • Risk and Issue Management, • Cross-Functional Team Management and Team Effectiveness, • Training and Facilitation, • and Portfolio ManagementI am enjoyed utilizing my breadth of drug development experience to delivering innovative medicines that will improve patient lives.
Stephen A Edwards's Current Company Details
Retired - Pharmaceuticals & Clinical Research Organizations
Retired from Pharma and Clinical Research Organizations
Stephen A Edwards Work Experience Details
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RetiredRetired - Pharmaceuticals & Clinical Research Organizations Sep 2024 - Present• Increasing time with family and friends• Increasing knowledge and time allocated to hobbies (landscaping & woodworking).• Improving physical fitness through time spent at gym• Continuous learning with new activities such as disc golf & pickle ball• Improving boating and fishing skills • Spending time travelling
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Director, Project Management Project Leadership Solutions LeadAllucent Jun 2024 - Sep 2024Cary, North Carolina, Us• Oversaw and optimized resource allocation processes, ensuring that projects are adequately staffed with Project Managers, Associate Project Directors, and Project Directors for Clinical Project Management (global). • Assigned available staff to projects based on their skills, experience, and availability; work with project managers to determine resource requirements for current and upcoming projects; forecast future team capacity and staffing needs; monitor employee utilization, workload, and overtime hours.• Provided ongoing resource management support to project managers; help resolve resource conflicts and allocation issues; monitor project progress and resource performance.• Developed and implemented effective resourcing strategies aligned with business goals; analyze resource utilization data to optimize allocation and improve efficiency.• Conducted regular meetings with project managers and other stakeholders; built and maintained relationships with department heads and team leaders; acted as a trusted advisor on recruitment and resourcing matters.• Served as key contact for multiple clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs. • Managed complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery.• Managed eight Project Managers, Senior Project Managers, and Associate Directors Project management and assist them in the execution of projects to a high standard of quality and within contractual budget and timelines. -
Director, Project ManagementAllucent Jun 2022 - Jun 2024Cary, North Carolina, Us• Served as key contact for assigned clients on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs.• Managed up to nine Project Managers, Senior Project Managers, and Associate Project Directors and assist them in the execution of projects to a high standard of quality and within contractual budget and timelines. • Worked across departments and locations to ensure Project Management staff is delivering a quality full-service product to its sponsors. • Oversaw all aspects of project development are conducted in accordance to sponsors requirements.• Managed complex, cross-functional resource requirements in line with budgeted, time, scope, and quality expectations for project delivery• Provided oversite on rare disease, allergy, and oncology studies.• Supported the recruitment and interviewing of new employees.• Managed resource forecasting and assignments for Clinical Project Management (Americas)• Balanced multiple competing priorities, with effective and efficient resource utilization across projects and programs.• Led portfolio of Phase 1 and Phase 2 oncology studies.• Developed and implemented Financial management tools.
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Associate Director, Clinical Research, Infectious & Respiratory DiseasesPpd Mar 2016 - May 2022Wilmington, Nc, Us• Provide team leadership, fostering effective team dynamics, and providing proactive communication to deliver the study, on time, within budget, and with quality• Responsible for providing leadership and oversight on Phase 1b to Phase 3 clinical studies• Serve as an escalation point for Sponsor and study teams• Maintains a can-do approach to address issues innovatively and proactively• Develop and drive the specific and overall therapeutic area strategies to ensure optimum performance and achievement of annual plans and targets.• Led program comprising of a Phase 2 and Phase 3 study.• Led multi-regional studies in SARS-COV-2, HIV, and tuberculosis. -
Clinical Development Manager, Infectious Diseases - Virtual Liver UnitGlaxosmithkline Jan 2014 - Mar 2016Brentford, Middlesex, Gb• Led the design, development, and start-up of a phase 1 first-in-human clinical study and development of a comprehensive clinical development plan for subsequent Phase 2-3 studies.• Prepared written scientific communications with clarity and accuracy. These include authoring study proposals, briefing documents, Phase 1 and Phase 2 clinical protocols, clinical study reports, clinical synopsis, Investigator’s Brochure, Development Safety Update Report, and internal and external stakeholder communication.• Demonstrated ability to devise and execute a clinical development strategy.• Designed and implemented FTIH study in a fully outsourced model.• Led value proposition and target product profile discussions on Infectious Diseases Therapy Area assets. • Contributed to the creation of the strategic business plan and portfolio management plans for portfolio of assets and indications within the Infectious Diseases Therapy Area. • Authored combined publication and manuscript for Phase 1 (FTIH) and Phase 2 (POC) studies -
Project ManagerGlaxosmithkline 2012 - 2013Brentford, Middlesex, Gb• Provided overall project management (including budget, resource, timeline and issue management) of cross-functional global dermatology projects (preclinical to post launch)• Demonstrated ability to develop working knowledge of therapeutic area(s) and apply learnings from other therapeutic areas• Contributed to value proposition discussions, target product profile, Commit to Candidate selection documents, and drug development strategy for GSK2981278 (psoriasis)• Contributed to value proposition discussions, target product profile, and development strategy for GSK2894512 (psoriasis and atopic dermatitis)• Contributed to the change management and embedding of change management practices within Project Planning and Management• Demonstrated understanding of the stages of drug discovery and end-to-end drug development and application of issue identification and development and application of risk mitigation strategies• Demonstrated effective situational leadership including leading sub-teams• Experienced in communication planning and stakeholder management
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Global Project LeaderStiefel, A Gsk Company 2011 - 2012Rtp, Nc, Us• Led cross-functional teams to establish strategies and effectively implement project development plans for Sorilux Globalization & Pediatric commitments and several branded generic products.• Championed projects through Stiefel governance bodies and stage-gates, including governance presentations to senior leadership.• Provided strategic and tactical leadership role fully accountable to drive and deliver the development of new products including leadership of due diligence and in-license activities for novel dermatology assets.• Established and developed team atmosphere by engaging team members in a common vision and mission.• Managed stakeholders within Stiefel/GSK and alliance partners.• Worked closely with Commercial and Portfolio Planning functions along with the project team to establish the target product profiles, development plan, and probability of technical success. -
Project ManagerGlaxosmithkline 2006 - 2011Brentford, Middlesex, Gb• Contributed to the progression and management of projects in multiple therapy areas (Infectious Diseases, Metabolic, and Neurosciences) by working with team to develop the strategy and manage the schedule, budget, and risk.• Contributed to the development of the value proposition statements and clinical development strategy for Phase 2/3 assets (restless legs syndrome, painful diabetic neuropathy, postherpetic neuralgia, and migraine prophylaxis).• Served as business lead (Project Management) on change management cross-functional initiative • Authored training materials on project management practices (project planning and schedule, risk, and budget management) for matrix team members.• Contributed to the HIV & HCV Discovery Performance Unit leadership teams and provided project and portfolio management support for multiple HIV and HCV programs.• Provided project management support for precandidate to Phase IV assets.• Revised disease area guides and project plan templates for Metabolic, obesity and Type 2 diabetes, and Infectious diseases, HIV and HCV.• Led and managed as Project Leader and Project Manager on the assessment, development and implementation of the risk mitigation strategy to ensure the continued availability of Albenza tablets for the treatment of Lymphatic filariasis.• Participated in six month rotation in Portfolio Management and contributed to project discussions to develop the asset profile and assess risk and probability of success.• Demonstrated ability to contribute to cross-functional teams, including Drug Discovery Product, Clinical Matrix, and Commercial Matrix teams.
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Manager, Pharmaceutical DevelopmentGlaxosmithkline 2004 - 2006Brentford, Middlesex, Gb• Led cross-functional teams responsible for the development and controls for active pharmaceutical ingredient (API) and drug product.• Led cross-functional teams for the development of solid dosage forms (capsules, tablets, modified release tablets, and fixed dose formulations).• Demonstrated knowledge of end-to-end process – from start (preclinical/lead optimization) to finish transfer to global manufacturing site (phase 3).• Coordinated the team’s activities to deliver scientific knowledge/understanding about the product, the process and the physical properties that ensures the process is robust, and the regulatory filings were successful.• Ensured that the Design for Manufacture (DFM) deliverables and Quality by Design (QbD) were met.• Developed strategies for expedited product development of Fixed Dose combinations Avandia with Redona and Metformin with Redona. Led the Redona/Avandia FDC product cross-functional team.• Managed Pharmaceutical Development project budget and plan and implement project plans to ensure drug substance and clinical trial supply materials.• Provided technical guidance and manage the development, validation, and documentation of analytical procedures for the characterization of drug product.• Supervised up to three direct reports.
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Research Investigator, Pharmaceutical Development,Glaxosmithkline 1998 - 2004Brentford, Middlesex, Gb• Physical Product Development leader for GW823093, GW825964, and Tucaresol cross-functional teams. Responsible for the physical product delivery plan and preparation of investigational dossiers.• Led cross-functional teams responsible for the physical product delivery plan and preparation of dossiers for successful international regulatory approvals and commercial launch of Zyban® Sustained-Release Tablets and Wellbutrin SR® Sustained-Release Tablets.• Supervised up to three direct reports.
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Analytical Sciences / Pharmaceutical DevelopmentGlaxosmithkline 1995 - 2000Brentford, Middlesex, Gb- Provided analytical support and/or led the development and validation of analytical methods for starting materials, critical synthetic intermediates, drug substance, pharmaceutical excipients, and drug product.- Authored CMC regulatory dossiers for MAAs, NDA, INDs, and CTAs.- Supervised up to two direct reports
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Analytical ScientistBurroughs Wellcome Company 1985 - 1995• Provided analytical support and/or led the development and validation of analytical methods for starting materials, critical synthetic intermediates, drug substance, pharmaceutical excipients, and drug product.• Authored CMC regulatory dossiers for MAAs, NDA, INDs, and CTAs.
Stephen A Edwards Skills
Pharmaceuticals
Pmp
Pmi
Pharmaceutical Industry
Gmp
Clinical Development
Drug Development
Analytical Chemistry
Validation
Fda
Regulatory Submissions
Technology Transfer
Clinical Trials
Drug Discovery
Stephen A Edwards Education Details
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East Carolina UniversityChemistry -
Appalachian State UniversityChemistry & Biology
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Appalachian State UniversityChemistry And Biology
Frequently Asked Questions about Stephen A Edwards
What company does Stephen A Edwards work for?
Stephen A Edwards works for Retired - Pharmaceuticals & Clinical Research Organizations
What is Stephen A Edwards's role at the current company?
Stephen A Edwards's current role is Retired from Pharma and Clinical Research Organizations.
What is Stephen A Edwards's email address?
Stephen A Edwards's email address is st****@****ppd.com
What schools did Stephen A Edwards attend?
Stephen A Edwards attended East Carolina University, Appalachian State University, Appalachian State University.
What skills is Stephen A Edwards known for?
Stephen A Edwards has skills like Pharmaceuticals, Pmp, Pmi, Pharmaceutical Industry, Gmp, Clinical Development, Drug Development, Analytical Chemistry, Validation, Fda, Regulatory Submissions, Technology Transfer.
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