Clinical Development Medical Senior Director

The Clinical Development Medical Senior Director leads innovative approaches to clinical development, develops and oversees implementation of solutions for complex problems with sustained and significant impact, and acts as subject matter expert for clinical development, influencing the decisions of senior leaders. They may lead or chair cross functional teams at the category or portfolio level including governance or advisory committees. They ensure medical & scientific integrity and the wellbeing of participants enrolled in clinical trials, design and execute high-quality studies, maintain compliance, manage risks and emerging clinical and medical issues, and support 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 provides matrix management.

Job Responsibilities

Leadership

Autonomously and independently leads clinical execution of one or more studies of high complexity and significant business impact. May be accountable for program level clinical deliverables.

Leads innovative approaches to clinical development, develops options and oversees implementation of solutions for complex problems.

May lead or chair cross functional teams at the category or portfolio level including governance or advisory committees.

Provides matrix management to clinical colleagues or a cross-functional team in clinical development.

Content Creation

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.

Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.

Clinical & Safety Oversight

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 SAP, TLFs and 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, 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.

Ensures TMF compliance for clinical documents

Clinical Reporting

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

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 7+ 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

PREFERRED QUALIFICATIONS

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.

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

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 might be required

Relocation support available

Work Location Assignment :

The annual base salary for this position ranges from $254,100.00 to $403,400.00. 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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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Medical