Director, Clinical Development Medical Director (MD Required)

Job Summary

The Director, Clinical Development Medical Director (MD Required):

• Is accountable for the medical & scientific integrity of the study and the wellbeing 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.
• Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. 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.
• Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review. Performs medical monitoring of one of more clinical trials.
• Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
• May also provide matrix management support of one or more R&D Internal Medicine clinicians on one or more clinical studies or across a clinical program.

Job Responsibilities

• Performs medical monitoring on one or more clinical trials:

• Provides study-related medical information and assistance, e.g., on:
  • medical questions from investigators, site personnel and non-study health care providers
  • safety findings, medical issues, and complex serious adverse events
  • audits or inspection medical responses

• Contributes to final significant quality event medical assessments.
• Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
• Reviews required safety text and endorses significant medical changes in the Informed Consent Document.

• 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 clinical/medical 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. Partners with/ supports the Global Development Lead in governance review and approval process.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical/medical input to the development of data collection tools. Responsible for providing clinical/medical input to SAP, TLFs and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical/medical 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 contributes to authoring and delivery of site training materials.
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol
• Reviews, reports and manages protocol deviations.
• 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 continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
• May provide matrix management support to one or more clinical colleagues.

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 a minimum of 4-years Clinical Development experience in industry/CRO.
• 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.
• Clinical research experience in phase 3/pivotal space  

• Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
• 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 excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer
• Demonstrated experience establishing, managing, and training teams in clinical development 

PREFERRED QUALIFICATIONS

• Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority preferred.
• Cardiometabolic disease experience highly preferred (ie; cardiology, obesity, endocrinology, nephrology, etc). 
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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 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.

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.

Medical