Clinical Development Medical Director, (MD Required)

The Clinical Development Medical Director (Director) is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. They may also manage, supervise, and mentor others.

JOB RESPONSIBILITIES

Provides medical monitoring on one or more clinical trials:

Provides timely, study-related medical information and guidance, e.g., on:

Medical questions from investigator sites

Medical issues in clinical trial data

Medical findings in audits or inspections

Contributes to medical assessments of Quality Events

Conducts and documents periodic safety data review and ongoing clinical/medical data review

Reviews Required Safety Text for the Informed Consent Document and significant medical changes in the Informed Consent Document

May independently lead clinical execution of one or more studies; may be accountable for program level clinical deliverables

May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters

Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions

Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests

Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures

Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock

Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives

Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations

Establishes and manages External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations

Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues

Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events

Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)

Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review

Ensures TMF compliance for clinical documents

Provides clinical input and review of the Clinical Study Report

Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to publications

Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings

May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests)

Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution

May have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop others

BASIC QUALIFICATIONS

As medically qualified individual, the successful candidate must have the following qualifications:

Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience in biopharmaceutical industry in clinical research and development.

Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.

PREFERRED QUALIFICATIONS

Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.

Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority.

Clinical research experience in the biopharmaceutical industry, in study design, start-up, conduct, and close-out, including regulatory submissions and inspections

Scientific productivity via publications, posters, abstracts and/or presentations

Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP

Clinical, administrative, and project management capabilities; effective verbal and written communication skills

Experience launching, managing, and training clinical development teams

Track record of achievement in pharmaceutical development; able to coordinate and execute clinical development during design, start-up, conduct, close-out, and reporting

Understands the complexities and recent developments in the principal disease areas; competent discussing scientific and regulatory aspects of drug development

Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities; able to define and manage resource requirements

Effective leader; able to mentor/coach, delegate to, and oversee others; able to develop others’ skills and move them toward autonomy

Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts; reads situations quickly; negotiates agreements; escalates issues when appropriate; takes responsibility for decisions

Shares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belonging

Takes personal responsibility for delivery of results

Able to demonstrate perspective and poise in uncertainty and organizational change

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel may be required

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

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