Clinical Development Medical Senior Manager

Job description

JOB SUMMARY The Clinical Development Medical Senior Manager is accountable for the: Medical & scientific integrity of the study and well-being of participants enrolled in one or more clinical trials. Timely delivery of high-quality protocols and clinical study execution. Clinical data, safety, risk review and mitigation. Use of AI-enabled clinical development and digital approaches to support excellence in clinical trial design and execution. JOB RESPONSIBILITIES Provides input to support development of the protocol design document. Leads or supports development and timely delivery of a quality protocol which maximizes operational efficiency, trial quality and participant / site engagement and minimizes the likelihood of amendments or quality issues. Provides clinical input to the DORA process to ensure application of data standards, optimized data collection, and timely and thorough data review using clinical data review best practice. Responsible for providing clinical input to the SAP, TLFs, and BDR. Manages Informed Consent Documents (ICDs) as per SOP including responses to external stakeholder questions. Provides clinical input to development of the Integrated Quality Management Plan (IQMP) as per SOP. Supports establishment and oversight of independent study committees, such as Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes. Inputs to, reviews, and approves the Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders, including clinical operations and the safety risk lead, to develop and implement any risk mitigations. Reviews and approves country selection, develops site selection criteria and ensures protocol specific training. Approves investigator meeting plans. Serves as the primary contact with external investigators and internal study team for questions relating to medical or clinical aspects of protocol. Reviews, reports and manages protocol deviations and approves protocol amendments as per SOP. Proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety, and protocol deviation review. Reviews patient level and cumulative data per the data review plan across one or more studies. Reviews safety data, SAE reports, TMEs, DMEs, and ICDs as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings. Performs medical monitoring for one or more clinical trials. Ensures Inspection Readiness for clinical documents. Supports appropriate interpretation and communication of clinical trial data. Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results. Provides clinical support to the study team or clinical program in response to audits or inspections Supports clinical sections of regulatory filings, including the Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, Periodic Safety Update Reports, and regulatory authority responses. May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs). Accountable for compliance with internal and external standards. Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution. Uses AI-enabled tools and analytics to support clinical data review, signal detection, and risk identification. Supports innovation, user feedback, and change adoption for digital clinical development tools. QUALIFICATIONS / SKILLS Education REQUIRED: MD or equivalent medical qualification PREFERRED: Postgraduate training/certification/fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.). Use of AI-enabled tools, automation, data visualization, or digital clinical trial technologies. PREFERRED QUALIFICATIONS Experience Strong experience and track record of success in biopharmaceutical industry in clinical research and development or academic clinical research . Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management. Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer. Demonstrated experience managing and training large teams in clinical development. Demonstrated experience in designing and launching large teams preferred. Demonstrated use of AI-enabled tools, automation, data visualization, or digital clinical trial technologies. Competency Requirements Medical / Scientific credibility/Excellence - Track record of achievement in therapeutic development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues. I&I clinical expertise is preferred. Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change Digital Innovation – Proactive approach to emerging technologies and able to apply digital and AI-enabled tools to improve clinical development quality, efficiency, and decision-making. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. Purpose Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Medical