Clinical Development Medical Director (MD required)

About the position

The Clinical Development Medical Director (Director) ensures medical & scientific integrity and the wellbeing of participants enrolled in clinical trials, designs and executes high-quality studies, maintains compliance, manages risks and emerging clinical and medical issues, and supports interpretation and communication of clinical data. This role is the primary contact for internal and external stakeholders for clinical and medical aspects the protocol, supports strategic development, and may provide matrix management.

Responsibilities

• Autonomously and independently le clinical execution of one or more studies of medium - high complexity and significant business impact.
• May be accountable for program level clinical deliverables.
• 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.
• Provides clinical/medical input to support development of the protocol design document (PDD).
• Le 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.
• Le development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• 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
• Provides clinical/medical input to the development of data collection tools.
• Responsible for providing clinical/medical input to statistical analysis plan (SAP), tables, listings, figures (TLFs) and blinded data review (BDR).
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP).
• Review and approves final document.
• 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
• 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 ICD.
• 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, serious adverse event (SAE) reports, targeted medical events (TMEs), designated medical events (DMEs) and ensures clinical documents (eg ICD) are updated as required.
• Tracks and reconciles SAEs across a study and le presentation of data during Safety Review Team meetings.
• Ensures trial master file (TMF) compliance for clinical documents
• 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 Clinical Trial Applications (CTAs)
• 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

Requirements

• 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 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

Nice-to-haves

• Oncology experience highly preferred
• 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.
• Demonstrates a passion for helping patients
• Proven analytical skills with the ability to work on large data sets
• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
• Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English
• Has a global perspective and mindset works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals
• Has solid understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance
• Proficient with basic IT; efficiently using a computer and telecommunications (voice and video)
• Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned
• Must have the relevant personality features and competencies supporting the responsibilities: Demonstrates effective problem-solving, and agile decision-making in execution of clinical responsibilities
• Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies
• Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
• Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes
• Has foresight and judgment in complex decisions: Leverages a variety of communication tools and techniques to communicate results
• Builds partnerships across the company to achieve the needs of the program Collaborative problem solving (handles conflict constructively)
• Promotes innovation and takes appropriate risks to challenge the status quo to enhance the efficiency of current processes
• Ability to work proactively and independently, organize tasks, time and priorities of self and others

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage