Linda Daly's Location
Norfolk, Massachusetts, United States, United States
Linda Daly's Contact Details
Linda Daly work email
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Linda Daly phone numbers
About Linda Daly
Experienced Clinical Director with a 30 year history of working in the Pharma industry including small and large Pharma, CROs, Generics and the Biotech industry. Experience in all phases of clinical research and a vast array of therapeutic areas including Oncology, Pain and Rare Diseases. Part of the team that successfully launched Vicoprofen and Embeda. Responsible for managing global teams as well as individual's career development.
Linda Daly's Current Company Details
Contractor, Clinical Project Manager
Linda Daly Work Experience Details
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ConsultantStemline Therapeutics May 2022 - Dec 2023New York, New York, UsOncology -
Contractor - Clinical OperationsImara Inc. Oct 2021 - Apr 2022Boston, Ma, Us -
Director, Clinical Operations Program LeadVertex Pharmaceuticals Dec 2019 - Mar 2021Boston, Ma, Us -
Senior Project DirectorPra Health Sciences Dec 2017 - Dec 2019Raleigh, North Carolina, Us -
Associate Director, Clinical Trials, OncologyEli Lilly And Company Aug 2011 - Nov 2017Indianapolis, Indiana, Us• Directs the planning and conduct of assigned clinical trials, including Phases I and II, registrational Phase III trials and all associated activities. • Accountable for the delivery of the trial according to plan, timelines, budget and quality standards. • Performs assigned responsibilities to ensure timely completion of project/departmental goals and objectives. • Accountable for CRO management and oversight of outsourced clinical activities. • Prepares and distributes ad hoc reports, summaries, and analyses. • Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, GCP, or regulations involving governmental agencies. • Responsible for the hiring, evaluation and oversight of the clinical staff -
Associate Director, Clinical Affairs, GenericsPerrigo May 2010 - Jul 2011Dublin, County Dublin, Ie• Responsible for protocol/amendment development (including review of all applicable literature such as SBAs, FDA guidance, and other publications), CRF design, modification/creation of ICF, Investigator Brochures, clinical supply calculations, development of study related forms/reports and source documents in collaboration with the CRO, Data Management Group and Biostatistics• Responsible for budget development, management and reporting• Project management of multiple Phase 1-4 clinical trials• Oversight of partnering companies• Responsible for the hiring, evaluation and oversight of the clinical staff -
Associate Director, Clinical Development, Rare/Orphan Disease IndicationsAmicus Therapeutics Sep 2008 - Jun 2010Princeton , Nj, Us• Directed all phases (I through III) of clinical trials.• Initiated first-ever Phase III program with 45 sites across 18 countries; met with FDA and gained agreement on the second pivotal Phase III study; assembled team of one Project Manager, one Project Associate and 4 CRAs; closed 4 Phase II studies and initiated and completed Single Ascending Dose as well as a Thorough QT studies required to initiate Phase III program• Identified specific strategies to support Clinical Operations activities, including interfaces with other departments and dependencies. • Led cross-functional team of senior level managers to coordinate implementation of clinical trials, align priorities and provide technical support to Clinical Operations staff.• Collaborated on regulatory issues to ensure all activities were in compliance with applicable regulations and guidelines. • Developed and managed project timelines.• Monitored changes to project plans and provided guidance to teams.• Ensured the quality of all Clinical Operations project deliverables. • Mentored and coached staff and team members. -
Associate Director, Clinical DevelopmentAlpharma Pharmaceuticals Feb 2008 - Jul 2008UsManaged various Phase I to IV pain programs for EMBEDA, Flector Patch and Diractin (ketoprofen gel). Maintained a high level of professional expertise through familiarity with clinical chronic pain literature and participation in project team meetings. Initiated and completed first-ever clinical program (EMBEDA subsequently approved). -
Program ManagerAlpharma Pharmaceuticals Jan 2006 - Feb 2008Us• Designed, planned and implemented the overall direction of clinical research projects; evaluated and analyzed clinical data. • Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. • Managed in-house Clinical Research Associates (CRAs). Served as primary liaison on timelines and logistics with a contract research organization. • Traveled to field sites to supervise and coordinate clinical studies. • Assisted in the completion of NDA applications. • Protocol/CSR writing and review. • Attended/led internal, external team and other meetings, as required, ensuring the timely completion of all projects/programs. • Helped team identify risks to projects and provided solutions to such risks. • Compiled benchmarking metrics and reviews to determine progress against corporate milestones and provided indications on areas requiring improvement. • Mentored direct reports, where applicable, improving on-the-job performance. .
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Project Manager/Project Leader, Multiple Therapeutic AreasKendle International 1997 - 2005Raleigh, North Carolina, Us• Designed and managed contract clinical research programs, including global projects, for the pharmaceutical industry by coordinating and overseeing all operational aspects of the clinical project across all functional areas. • Developed, negotiated and monitored timelines and milestones; developed, negotiated and managed study budgets; tracked and reported project status, issues and concerns. Additionally made recommendations to client and/or management.• Acted as liaison between the client and Kendle, and other contract organizations such as central labs, central IRBs, and/or other third party vendors. • Developed Project Plan and Project Specific Operating Procedures; assessed scope of client contract, initiated change of scope orders when appropriate.• Ensured quality standards and customer satisfaction; monitored project team performance; provided a leadership role through the mentoring and oversight of other Project Managers• Developed and managed strong relationships with sponsors; and liaised with Kendle management. • Served as Line Manager for team of CRAs; managed career development efforts and appraisal process. -
Global Study ManagerHoffmann-La Roche 2003 - 2004Switzerland 🇨🇭 , Ch• Provided clinical trial management expertise and direction to the study management team (SMT).• Contributed to the development and finalization of the protocol, study procedures, documentation, CRF and data quality plan. • Defined clinical operations specific procedures and ensured dissemination of relevant study information to the SMT. • Defined resource requirements and provided input for the budget/financial plan including overall study cost, guidelines for site budgets and payment schedules. • Tracked and adjusted budget to meet study requirements. • Established priorities for clinical operations tasks and ensured resolution of critical activities. • Developed, implemented and monitored strategy for clinical operations that met study timelines, milestones and goals. • Led the clinical operations team and delegated appropriate tasks, assignments and responsibilities. • Created and facilitated meetings and training sessions for specific protocol and study related processes. • Planned and implemented country and site selection, overall drug supply and provision of other study materials. • Provided input to SMT for the selection of global external vendors. Oversaw CRO activities when operations tasks were outsourced. • Maintained knowledge of current global regulatory guidelines relevant to clinical operations and ensured all activities within the SMT were conducted according to SOPs and documented best practices. -
Lead Clinical Research Associate, Allergy And AsthmaSchering-Plough Pharmaceuticals 1996 - 1997Rahway, New Jersey, UsServed as Lead Monitor for 16-center, 3-month asthma study. Accountable for contract and budget negotiation, IND documents, and clinical supplies for all centers. Personally monitored 6 sites and managed the CRO monitoring the remaining 10 sites. Designed case report forms/diaries. -
Clinical Research Associate, Medical Affairs DepartmentKnoll Pharmaceuticals 1991 - 1996East Greenville, Pennsylvania, UsMonitored Phase I to IV Analgesic studies for Vicodin, Vicoprofen and Dilaudid as well as post-marketing studies for other compounds (including dermatology and cardiovascular). Identified and recruited potential investigators; negotiated contracts and budgets; designed/wrote protocols, case report forms, and diaries; initiated and monitored studies; reviewed/edited data listings; performed QA of clinical laboratory reports and methods; wrote integrated reports of Safety and Efficacy, Investigator Brochures, and Package Inserts; and collaborated on compilation of NDA. Managed the pivotal multiple-dose safety trial of Vicoprofen in chronic pain patients. -
Research AssociateCelgene 1988 - 1990Benchtop research involving optimization of natural capabilities of microorganisms to synthesize commercially valuable chemicals for agricultural and pharmaceutical industries. Work involved HPLC, GC, polarimeter, French press, enzymes assays and classical assays.
Linda Daly Education Details
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Rutgers UniversityMedical Technology -
Umdnj - School Of Health Related ProfessionsClinical Laboratory Science/Medical Technology/Technologist
Frequently Asked Questions about Linda Daly
What is Linda Daly's role at the current company?
Linda Daly's current role is Contractor, Clinical Project Manager.
What is Linda Daly's email address?
Linda Daly's email address is ld****@****ine.com
What is Linda Daly's direct phone number?
Linda Daly's direct phone number is +197849*****
What schools did Linda Daly attend?
Linda Daly attended Rutgers University, Umdnj - School Of Health Related Professions.
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