About Tahira
English
Native or bilingual
Experience
- Vaccines, AstraZeneca UKSenior DirectorAugust 2022 - August 2023 (1 year)• Regulatory Authority Management: Oversaw and facilitated the timely response to inquiries from regulatory authorities, assigning the appropriate departments or personnel to ensure comprehensive and accurate submissions. Proactively managed the regulatory query resolution process to ensure compliance and minimize delays.• Crisis Management and Reporting: Led the tracking and reporting of Variants of Concern during the Covid 19 pandemic, providing senior leadership with weekly status updates and actionable insights to inform decision-making and ensure regulatory compliance in a rapidly evolving environment.• Real-World Evidence Strategy: Identified and leveraged real-world evidence (RWE) data to support regulatory and clinical responses, enhancing the organization's position in regulatory submissions and ongoing clinical research strategies.• Team Development and Training: Directed the development and implementation of training programs for team members, enhancing knowledge, skills, and departmental performance while fostering a culture of continuous learning and growth.• eTMF Implementation and Oversight: Led the successful implementation and management of the department's electronic Trial Master File (eTMF) system, ensuring compliance with industry standards and regulatory requirements while streamlining document management processes.• Vendor Management and Procurement: Managed the selection, negotiation, and performance oversight of key vendors, ensuring timely delivery of services and maintaining quality standards in alignment with project goals and budgets.
- CellCentricContract - Clinical Development DirectorOctober 2020 - June 2021 (8 months)Reporting to the CEO and COO, leading clinical programs and responsible of managing cross functional project team matrix. Summary of responsibilities as follows:• Enhanced Staff and Site Productivity: Spearheaded training initiatives that significantly increased staff efficiency and site productivity, optimizing trial timelines and improving overall operational performance.• Led International Expansion: Successfully led the strategic expansion of clinical trials into European markets, navigating regulatory requirements and establishing strong partnerships to accelerate trial execution across multiple regions.• Leadership and Development: Provided ongoing guidance, coaching, and mentorship to team members, fostering a culture of continuous improvement and professional growth through timely feedback and performance development strategies.• Stakeholder Engagement and Representation: Represented the organization at industry conferences, promoting trial findings and fostering relationships with key stakeholders. Actively contributed to fundraising efforts by showcasing the organization's capabilities and aligning clinical trial outcomes with investor interests.• Budget Management and Efficiency Optimization: Managed multi-million-dollar trial budgets, implementing targeted strategies to drive efficiency and ensure financial discipline. Developed and executed plans to maximize resource utilization, delivering trials on budget while maintaining high quality and compliance.
- THERAGNOSTICSContract - Director Clinical DevelopmentSeptember 2017 - September 2019 (2 years)Reporting to the CEO and COO, leading clinical programs and responsible of managing cross functional project team matrix. Summary of responsibilities as follows:• Design Clinical Development Plans and define the objectives, strategy, milestones and resources required up to registration.• Key member of the Project Core Team, representing Global Clinical Development and company and external meetings while providing guidance to Clinical Study Teams.• Strategically lead the execution of clinical trials through CRO management and leadership of the internal team.• Responsible for clinical related documents (eg.IND, IB, briefing package for regulatory authorities, ISE, ISS, publication), and the presentation of compound, protocols and results at expert meetings, advisory boards and regulatory authorities.• Vendor selection, monitoring and budget negotiation.• Represent as a clinical interface and actively solicit key opinion leader interactions.• Providing guidance, performance/ career development coaching and mentoring with timely feedback to the Team.
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Education
- Post graduate diploma in Clinical Research,University of Liverpool2006Post graduate diploma in Clinical Research,
- BSc (Dual Honors) Physiology and Pharmacology,University of Nottingham Trent1999BSc (Dual Honors) Physiology and Pharmacology,