aktaPD’s® experts personify our action-oriented work ethics. These seasoned, vetted professionals, listed by category, are ready to leap into action for your next short-term or long-haul project. Their goal? To bring their vast knowledge, experience, and innovation to your team and leverage your resources and extend your capabilities so you can meet your goal.
14 years in medicine and 9 years in academics and clinical research.
EXPERTISE Clinical Research; Genitourinary (GU) Oncology Clinical Trials, Medical Device Development Trials; Academic and Clinical Medicine; Medical and Legal Interpreting (Russian and Ukrainian); Specialties: Urology and Oncology (Prostate Cancer, ... Read More
EXPERTISE Anesthesiology, Clinical Pharmacology, Surgery, Internal Medicine, Regulatory Affairs. Deep experience in regulatory affairs and project management including finding and contracting investigators and ... Read More
EXPERTISE Event Planning, Project Management, Sales & Marketing, Account Management. Classically trained in the European school of world class hospitality and in developing, motivating, managing, training, and leading diverse teams in short- and long-term corporate ... Read More
EXPERTISE International Pharmacovigiliance (Phases I-IV); Medical Specialties: Cardiovascular, Dermatology, Endocrinology, Gynecology, Hematology, Neurology, and Oncology; EDC Specialties: ARISg Safety System, DataFax, DATATRAK (Data System Blinded), Medidata Rave, and OmniComm; BSN/Registered Nurse. Associate Director of Pharmacovigilance, Pharm-Olam Overall responsibility ... Read More
MEDICAL DIRECTOR/MEDICAL AFFAIRS – CNS/ONCOLOGY/VIROLOGY PERSONAL PROFILE
40+ years as a medical practitioner, 33 years in medical research, and 23 years in the pharma industry.
EXPERTISE CMO/Senior Medical Executive; Clinical/Protocol Development, Life Cycle Management, and Global Strategy of Therapeutic Agents; Global Medical Affairs; Statistics; Regulatory Affairs; Biotechnology; ... Read More
30 years of experience in drug development across a diverse range of therapeutic areas and product types.
EXPERTISE Global Regulatory Affairs, Oncology and Infection, Neuroscience, Drug Development, Seasoned Executive, Strategic Thinking, Internal Change Management. PROFESSIONAL EXPERIENCE Vice President, Regulatory Affairs, Oncology and Infection, ... Read More
ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE
14 years experience in pharmaceutical industry; 20+ years as a surgeon and intensive/emergency care physician.
EXPERTISE CMO; Design, Implementation, and Execution of Global Clinical Trials and Key Documents (Phases 1 to 3); Clinical/Regulatory Strategic Planning; Global Regulatory and IND/NDA Submissions (US, EU, ... Read More
27 years as a Hematologist/Medical Oncologist, 20 years of clinical practice experience, and 3 years as a physician executive.
EXPERTISE Physician Executive, Medical Affairs, FDA Label Approvals, Oncology Genomic Profiling, Global Management in Oncology Therapeutics and Cancer Molecular Diagnostics, Clinical Studies Oversight, ... Read More
Clinical Research, Program Operations PERSONAL PROFILE
14+ years in project management, clinical operations, and clinical trials; 12+ years of team management.
EXPERTISE Drug Development; Clinical Trials Policy and Procedure Development; Database Creation and Management; Budget and Contract Development; Research and Medical Writing; CNS Neurology – Traumatic Brain ... Read More
27 years in clinical project management and innovation.
EXPERTISE Clinical Project Management, Innovation, and Technology; SOP Development; Process Improvement; Vendor Selection and Management; Early-Stage and Post-Marketing Global Clinical Development; Large-Scale Global Phase II-IV Pharmaceutical Studies; Relationship-Building and Management; Training Development and Facilitation; Public Speaking ... Read More
15+ years of professional experience as a scientist and executive working in oncology.
EXPERTISE Scientist/Researcher, Oncology Specialty, Start-ups, Angel Investment/VC, Business Development and Strategy, Management Consultant. PROFESSIONAL EXPERIENCE Management Consultant, DavCard Group and MedPharma Partners Provide advisory services to VC portfolio ... Read More
COMPLIANCE/QUALITY SYSTEMS SPECIALIST PERSONAL PROFILE
25 years of US and international experience in pharmaceutical and biotechnology manufacturing and testing, medical devices, and product development.
EXPERTISE Quality and Regulatory Compliance Support for Pharmaceuticals, Medical Devices, and Chemical Reagents; Audits; Supplier Qualification; Optimization of Contract Manufacturers, Testing Laboratories, and Suppliers; ... Read More
MEDICAL EXECUTIVE, CLINICAL DEVELOPMENT PERSONAL PROFILE
20+ years as a pharma executive, 27+ years in clinical development, and 30+ years as a physician.
EXPERTISE CMO; Clinical Development (drugs, biologics, and medical devices); Global Clinical Trials (Phases 1 – 4); Product Registration and Post-Marketing Activities; Project Management of INDs, ... Read More
EXPERTISE Biostatistician; Statistical Analysis; Clinical Development Program and Trial Design; Adaptive Designs and Implementation; Statistical Support of Biomarker Development; Technical Oversight/Guidance of Statistical Analysis Vendors; Software Design, Development, Testing, and Refinement. Authored nearly 100 peer-reviewed publications and ... Read More
25 years in F100 and Life Sciences Information Technology
EXPERTISE Project Management, Six Sigma, Systems Integration, Technical Architecture and Custom Software Development. Senior leader with proven ability to drive projects successfully and to collaborate with a wide variety of people in ... Read More
30 years of experience in domestic and international pharmaceutical and medical device industry.
EXPERTISE Regulatory Affairs, Clinical and Quality Assurance/Compliance and Operations Systems, GCP Compliance, Project Management, Investigational (IND, IDE, CTA, CA, and EC submissions) and Marketing Applications (NDA, BLA, and PMA; MAA ... Read More
CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT PERSONAL PROFILE
11 years in clinical operations support.
EXPERTISE Operations Management, Information Systems Management, Regulatory Affairs Management, Fiscal Management, Clinical Trial Assistant (cardiology, dermatology, device, gynecology, gastroenterology, oncology/hematology, urology), Process Analyst, Data Flow Analysis and Documentation of US Clinical Trial Process, ... Read More
25 years in production and project management of meetings and special events, specializing in pharmaceutical, corporate and technological industries
EXPERTISE Project Timeline Creation, Workflow Scheduling, Budget Development, Administration and Reconciliation, Meeting Theme Branding. PROFESSIONAL EXPERIENCE Director, Productions – The Right Plan (TRP) ... Read More
RESPIRATORY / IMMUNOLOGY & REGULATORY AFFAIRS PERSONAL PROFILE
15 years as a research/clinical development physician in the pharma industry.
30 years in medicine.
EXPERTISE Physician Executive, Global Drug Development, Chief Medical Officer, Clinical Research, Clinical Trials Design and Implementation, Principle Investigator, Rare and Orphan Indications, International Regulatory Affairs/Filings, ... Read More
PROJECT MANAGER PERSONAL PROFILE More than 20 years of diversified experience in the administrative and customer service fields. EXPERTISE Project Management, Data Research and Compilation, Query Testing, Global Transparency Reports, Customer and Financial Reports (CTMS data validation), Sponsor Liaison, Sponsor Documentation (files, records, and reports), File Review and Audit, ... Read More
PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT PERSONAL PROFILE
24 years in clinical development of investigational therapeutic and diagnostic products.
EXPERTISE Clinical Operations; Monitoring; Clinical Research Line Management; Domestic and International Phase 1-4 Pharmaceutical Studies and Pilot, Pivotal, and Post-market Medical Device Studies; Investigational Site Feasibility and ... Read More
EXPERTISE Cost Management, Process Improvement, Functional and Operational Efficiency, Strategic and Development Planning, Vendor Evaluation, Third Party and R&D Integration, Gap Analysis, Collaboration/Accountability/Decision-Making, CRO Partner Management. PROFESSIONAL EXPERIENCE Founder and Principal, Professional Clinical Consultants, LLC Provides ... Read More
13 years in pharma industry oncology clinical development
EXPERTISE Practicing Radiation Oncologist, Oncology Clinical Trials (Phases I-IV), Chief Medical Officer, Global Clinical Development, Research (academic and pharma), Regulatory Filings, Commercialization, Strategic Decision-Making and Operational Processes, ... Read More
EXPERTISE Clinical Trials; Compliance; Protocol Synopsis/Development; Project Budgets and Timelines; Management of Field CRAs and Internal Project Coordinators; Vendor Selection, Oversight, and Audit (CROs, labs, imaging, drug distribution); Patient Recruitment and Retention; SAEs and Regulatory Reporting; Site ... Read More
30+ years in global clinical development, medical affairs and translational research.
EXPERTISE HIGHLIGHTS Global Clinical Development of Drugs/Devices/Diagnostics; Global Clinical Operations (registration, launch, post-launch, and study publications); Pharma Executive; Scientific and Industry Experience in Rheumatology/Autoimmune/Inflammatory Diseases, Oncology, and Hematology; Compliance, QA and Regulatory; Tenured ... Read More
EXPERTISE Clinical Data Management, Database Developer, EDC/Site Vendor Selection and Management, Process Improvement, SOP Development, Internal Data and Sponsor Audits, Data/Vendor Management Plans, Case Report Form Authoring/Library, Protocol Violation Reporting, Adverse Event Management, Proposal Writing, GCP, ICH, and ... Read More
EXPERTISE Mood and Psychotic Disorders; Research Psychiatry; Therapeutic Neuromodulation ECT (electroconvulsive therapy) and TCM (transcranial magnetic stimulation); Psychiatric Drug Development (psychosis and depression); Clinical Trials; Management and Treatment of Schizophrenia, Depression and Bipolar; Psychopharmacology; ... Read More
LEADERSHIP / CLINICAL DEVELOPMENT PERSONAL PROFILE
29 years in drug development.
EXPERTISE CMO, Operational Oversight, Strategic Planning & Development, Clinical Development and Medical Oversight, Negotiating and Influencing, Team Leader, Line Manager, Team-Building, and Engagement. PROFESSIONAL EXPERIENCE Pharmaceutical Consultant, Harrigan Consulting, LLC Strategic review partner for venture investors in ... Read More
24 years in pharma medical management/leadership and commercialization strategies.
EXPERTISE Global Medical Leadership, Strategy and Operations, Commercial Assessment, In-Licensing, R&D, Medical Affairs, Marketing and Sales, Business Development, Change Management, Physician, Specialties: Small Molecules/Biopharmaceuticals, Hospital Internal Medicine, Cardiology, Immunology/Inflammation, Ophthalmology, Cardiovascular Diseases, Diabetes Mellitus, ... Read More
ONCOLOGY, CLINICAL DEVELOPMENT, IMAGING PERSONAL PROFILE
15 years of pharmaceutical industry and clinical research experience.
EXPERTISE Clinical Development, Imaging, and Research (oncology, small molecules, biologics, medical devices, and diagnostics); Clinical Development Plans; Scientific, Medical, and Operational Leadership of Clinical Trials (all phases); Clinical and Regulatory Strategy; Protocol ... Read More
COMPLIANCE, QA, & REGULATORY AFFAIRS PERSONAL PROFILE
13 years in the compliance field.
EXPERTISE Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Foreign CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); ... Read More
KOL & ENGAGEMENT AND MARKETING EXPOSURE PERSONAL PROFILE
30 years in medical and pharmaceutical arenas
EXPERTISE Site and Patient Management, Key Opinion Leader (KOL) Development, Establishing Relationships, Competitive Intelligence, Patient Advocacy Groups and Professional Societies, Negotiations, Strategic Planning/Analysis. PROFESSIONAL EXPERIENCE Director, Medical and Professional Services – Merz ... Read More
EXPERTISE Certified Clinical Data Management Professional; Oncology; Project Management; CRO and Vendor Management; Process Improvements; SOP Development; Data/Vendor Management Plans; Standards Creation and Management; Contracts and Financial Analytics; Process Improvement; GCP, ICH, and GMP Compliance; Cross-Departmental Trainer of ... Read More