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About the Role

The Clinical Development Medical 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.

Responsibilities

Provides medical monitoring on one or more clinical trials.
Provides timely, study-related medical information and guidance.
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 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.
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.
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.
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.
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.
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.
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.

Requirements

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.
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.
Global travel may be required.
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.

Skills

Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.
Medical monitoring
Clinical trial oversight
Data integrity
Quality assurance
Medical assessment
Safety data review
Informed Consent Document review
Protocol design
Protocol amendments
Statistical Analysis Plan development
Clinical data collection strategy
Safety Review Plan development
Risk Management Plan development
External Data Monitoring Committee management
Adjudication Committee management
Site selection criteria development
Protocol training delivery
Investigator meeting planning
Protocol deviation management
TMF compliance
Clinical Study Report review
Regulatory filings contribution
Process enhancement
Mentoring
Supervision
Team management
Project management
Communication skills (verbal and written)
Leadership
Conflict resolution
Negotiation

Location

Hybrid

Work Type

Hybrid

Experience Level

4+ years of experience in biopharmaceutical industry in clinical research and development
2+ years post their intern/house officer/foundation period licensed to prescribe medicines independent of Supervision

Education Level

Primary medical degree (e.g., MD, DO, MBBS, MBChB)

Salary/Compensations

$239,900.00 - $399,800.00
Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary
Eligibility to participate in our share based long term incentive program

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available

About the Company

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users.
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.

Equal Opportunity

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.