Clinical Development Medical Director, Inflammation & Immunology

JOB SUMMARY

• The Clinical Development Medical Director is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence.
• Responsible for effective execution of studies and works in close partnership with Clinical Operations team members. The Clinical Development Medical Director is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex clinical trials and supports appropriate interpretation and communication of clinical trial data.
• The Clinical Development Medical Director maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review. Performs medical monitoring of one of more clinical trials.
• The Clinical Development Medical Director will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.
• Provide matrix management support of one or more clinicians on one or more clinical studies or across a clinical program.
• Use of AI-enabled clinical development and digital approaches to support excellence in clinical trial design and execution.

JOB RESPONSIBILITIES

• Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.
• Provides input to support development of the protocol design document (PDD).
• Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues.
• Provides clinical input to the DORA process to ensure application of data standards, optimized data collection and both timely and thorough review of data through the use of clinical data review best practice. Responsible for providing clinical input to SAP, TLFs and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Inputs to, reviews and approves, Risk Management and Safety Review Plan. Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead etc) 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 clinical aspects of protocol
• Reviews, reports and manages protocol deviations and approves protocol amendments.
• Reviews patient level and cumulative data per the data review plan across one or more studies.
• Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
• Acts as the medical monitor on one or more clinical trials.
• Ensures TMF compliance for clinical documents
• 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, including providing support as needed to audit/inspection
• May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs)
• Contributes to continuousimprovement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
• May provide matrix management support to one or more clinical colleagues.
• Proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety, and protocol deviation review.
• 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
BASIC QUALIFICATIONS
Education

• MD (or equivalent)

PREFERRED QUALIFICATIONS

• Postgraduate training/certification/fellowship in Dermatology, Rheumatology or Pulmonology
• Postgraduate training/certification/fellowship in drug development.
• Experience • 5+ years of experience and track record of success in biopharmaceutical industry in clinical research and 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.
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, 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

This is a hybrid role requiring an average of 2.5 days on-site and must be commutable to a site.
The annual base salary for this position ranges from $239,900.00 to $399,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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