Zainab Mukhtar
Medical Doctor
Wiesbaden
Summary
Medical Physician with proven expertise and knowledge in interventional and non-interventional studies in industry. Experienced in early, and late phase clinical trials of drugs, diagnostics and vaccines. Track record of working in complex regulatory environments and regions, while handling feasibility studies, protocol planning, study execution with matrix teams and supporting the target product profile. Proven expertise in hemato-oncology/immunology, and infectious diseases, while accumulating experience of working with cross functional teams in various programs since 15 years. Through skills and track record of handling big data sets, while understanding disease biology, pharmacokinetics, translational science, and focusing on patient safety and data integrity elements. Experience in preparing and conducting interactions with global health authorities (e.g. EMA, FDA).
Overview
15
15
years of professional experience
5
5
Certifications
6
6
Languages
Work History
Medical Expert Clinical Trials
BioNTech
Mainz
01.2021 - Current
- Comirnaty COVID-19: 162-01, 162-04, 162-14 and now 162-21 as Medical Expert
- Also reviewing trial documents from Pfizer led clinical trials PF-07926307 (Combination COVID-19 and Influenza mRNA Vaccine)
- Tuberculosis: 164-01 as Clinical Study Lead (German Trial) and contributing in phase2/3
- Strategy and Design: Hands-on, Development and amendments of CTPs ensuring that it is appropriately aligned with clinical strategy
- Assumed responsibility of study lead, when assigned, and articulated TPP and CPP objectives to other functions
- Coordinating with the CTMs, MSPV, CMC, Biostatistics, and other team members in trial execution, monitoring milestones, and for reviewing all trial documents from Clin dev perspective
- Handling operational risks/challenges with responsible CTMs, communicating with study site (IRBs), Investigators (managing relationship and handling queries), and guiding vendor (ICON) where Clin Dev feedback is required
- Also, responsible Clin Dev representative at site initiation planning and execution
- Developing trial content (status and safety results) and presenting to Pfizer every month- in JSRT meeting for all the COVID trials mentioned above
- And responsible for handling all feedback and reviews
- Responsible for contribution in DSURs, Investigator Brochures, Investigational Product Labelling, IMPDs, briefing documents, letters to regulators during trial and providing feedback on regulatory queries pre inception and during trial, ct.gov record updates, interim reports, and final clinical study reports
- Responsible to review the trial data, plan TFLs delivery, plan data cuts for interim analysis, conduct data cut shell reviews, and check for the data quality in addition to monthly and ongoing medical review of the trial data and vendor oversight
- Responsible for review of IRC/SRCs data and handling any communication with PI for related queries when required
- Contribute to interactions with study investigators, advisory meetings with opinion leaders
- Develop trial related presentations for senior leadership
- Provide site selection inputs, developed site selection feasibility guidance (TB program), , and presented overview of all available TB vaccines reactogenicity (TB program)
- Responsible from trial Clin dev dept, review for CTP deviations, dose management plan, SAP, MMP, PDP, SMPs, Blind Management Plans, all trial related CAPAs, also drafting NTFs from Clin dev when appropriate
- Fully responsible to Support pharmacovigilance activities with medical input (e.g., contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings, providing inputs to SMPs, risk/benefit assessment plans per trial
- Providing assigned inputs, in the clinical development plan for new compounds and/ or indications and Clin dev inputs in all trial related publications when planned (example: post-transplant publication 162-14)
- Work with CTM, PMs in providing input/guidance related to trial roles and responsibilities matrix, timelines, and budget
- Keeping a keen eye on trial relevant clinical literature/publications to ensure being up to date with the competitive landscape and can provide authentic input based on data to relevant internal/external teams
- Actively presented in ID Journal Club on regular basis
- Training Coordinator for Global Clinical Development Team, All Portfolios, assigned as part of job description officially since April 2022: Working for induction, and training support to all new employees, reviewing and revising Clin Dev related SOPs when required, streamlining training groups organization in GCDO, and SOP guard system export to Veeva
- Contributed as a contributor and/ reviewer in several Clinical, Operational ad Safety Management related Standard processes
- Volunteered to support Afrika Kommt fellow, in TB programme
- Recently volunteered for TDR Clinical Research Leadership fellowship program and provided all inputs for selecting fellows
Global Medical Lead
Abbott
Wiesbaden
01.2015 - 12.2021
- Countries worked in: Africa (South Africa, Tanzania) Middle East, Asia (India, Vietnam, Pakistan, Bangladesh)
- Programs: COVID-19, Malaria, Transfusion Transmitted Infections (HIV), Hematology Diagnostics, Cystic Fibrosis (phase2), Solid Tumors (veliparib in combination with temozolomide phase 2)
- Research Strategy and Feasibility Lead: Clinical Lead and Co-Lead of various studies (tasks included Clinical study design, planning, organizing in England, Italy, Netherlands, Germany and South Africa)
- Preparation of study documents including sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages)
- Design, author, and implement clinical development plans; contribute to preparation of product and therapeutic area related strategy documents
- Responsible for all COVID 19 hematology research projects
- Produce training materials, relevant to the program thematic areas, and provide training to broader study teams
- Fully responsible to Support pharmacovigilance activities with medical inputs
- Conduct high quality data review, with emphasis on safety, eligibility, trends identification, analysis and identification of important cases for team medical review
- Drafted as first author, subject specific white papers, peer reviewed manuscripts, learning guides, patient case studies
- Identifying key opinion leaders
- Developed AD Boards, Presentation of papers and scientific content in symposia, conferences
- Support to EU-IVDR Project for hematology diagnostics: Drafting scientific validity reports, medical platform documents- FDA 510K submission
- Developing of training courses and conducting training workshops for clinicians and internal teams (Sales, marketing, service and application)
- Supported internal stakeholders such as marketing, market access, MSLs, regulatory affairs, pharmacovigilance, legal affairs, data analytics, Business excellence with relevant medical and strategic inputs
- Provide medical and strategic inputs for design of Phase 1, 2 and 3 studies for early products
- Responsible for HCP requests and Inquiries related to products (Complains, Risk assessments)
- Represented and handled Abbott MSA matters with regulatory bodies organizations FDA; MHRA and EMA
- Received various Excellence awards at Abbott
Consultant
GFA Consulting Group
01.2010 - 12.2015
- dwInternational Infectious Diseases Projects (Hepatitis, Malaria, and HIV/Blood Safety)
- Donors worked for: Novartis Vaccines and Diagnostics, GmbH, Marburg, Germany
- WHO, GIZ, KFW, EU
- Developing Clinical Study Project Designs, Protocol writing, operational feasibility planning and conduct, Technical and Financial Management plans/Funding proposals for donor agencies
- Developing plans for supporting local diagnostic facilities in Asian, and African sites (GMP and GCP)
- Training and capacity development of project workforce, monitoring site data in HIV/blood safety
- Creating Dossier for evaluation for contracting agencies
- Managed Projects in Germany, Turkey, Pakistan and Some Countries of Asia Pac
- Consultant Team Management, Hiring and TOR development Experience
- PPP-Management, Stakeholders Mapping etc
- Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
- Established a robust network of healthcare professionals, fostering partnerships that led to increased business opportunities.
- Gathered, recorded and analyzed disease, customer, market and competitor intelligence gained from stakeholder interactions, meetings and literature.
Education
Medical Doctor (MD) -
University of Karachi
Resident/Fellowship - Internal medicine and infectious diseases
University of Bristol, South Mead Hospital
Combined specialist training - hematopathology and immunology
NHSBT
Filton, UKTraining - Oxford vaccine center
The Jenner Institute Laboratories
MSc - Immunology, transfusion and transplantation
NHSBT
Filton, UKMBA - Public Health Management
IoBM
Karachi, PakistanSkills
Teamwork and collaboration
Time management
Clinical Trial Protocol design
Biostatistics, tools
Regulatory framework expertise
Pharmacovigilance
Good Clinical Practise
Certification
Assessor and Inspection training, Paul-Ehrlich-Institut, Langen Germany
Publications
- Clinical utility of extended red blood cell parameters in differentiating β-thalassemia trait and iron deficiency anemia patients on iron therapy, Int J Lab Hematol, 12/01/21
- Enlargement of the WHO international repository for platelet transfusion-relevant bacteria reference strains, Vox Sanguinis
- A global survey of clinicians' awareness, accessibility, utilization of e-continuous education, and quality of clinical blood use: policy considerations, Int J Clinical Transfusion Medicine
- External financial aid to blood transfusion services in sub-Saharan Africa: a need for reflection, PloS Medicine
- Laparoscopic Surgery for an Ileal Stricture Secondary to Chemotherapy in Paediatric B-Cell Non-Hodgkin Lymphoma, Hellenic Journal of Surgery, 2013
Personal Information
Age: 44
Timeline
Medical Expert Clinical Trials
BioNTech
01.2021 - Current
Global Medical Lead
Abbott
01.2015 - 12.2021
Consultant
GFA Consulting Group
01.2010 - 12.2015
Combined specialist training - hematopathology and immunology
NHSBT
Training - Oxford vaccine center
The Jenner Institute Laboratories
MSc - Immunology, transfusion and transplantation
NHSBT
MBA - Public Health Management
IoBM
Medical Doctor (MD) -
University of Karachi
Resident/Fellowship - Internal medicine and infectious diseases
University of Bristol, South Mead Hospital
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