Clinical Development Scientist, Senior Manager

The Clinical Development Scientist (Senior Manager) is responsible for 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 supervise and mentor others. JOB RESPONSIBILITIES Provides clinical support for one or more studies; may be accountable for program level clinical deliverables May provide input to the protocol design document; contributes to development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters Supports the study team in internal protocol review governance submissions and interactions; supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions May develop Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests Provides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures Provides clinical input 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; performs clinical data review; may present 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 input to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and may update clinical documents in response to emerging safety profile; tracks and reconciles Serious Adverse Events; participates in clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives Provides clinical input to the development of the Risk Management Plan; conducts clinical activities consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations Supports establishment and management of External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendations Contributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleagues Participates in investigator meeting planning and may develop and deliver protocol training; may develop and deliver ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events May serve as a clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; contributes to clinical response development, delivery, documentation, and curation (e.g., in FAQ) May author protocol deviation sub-categories; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; may lead protocol deviation trends review Ensures TMF compliance for clinical documents Provides clinical input and review of the Clinical Study Report Provides clinical support to 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 supervise, mentor, or develop others BASIC QUALIFICATIONS Science degree (PhD, PharmD, or equivalent) with at least 1 year, or MA/MS with at least 5 years, or BA/BS with at least 6 years of Clinical Research experience in a similar role in the biopharmaceutical industry PREFERRED QUALIFICATIONS Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc. 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 Knowledge of clinical development, global and regional regulation, and ICH/GCP Clinical and administrative capabilities; effective verbal and written communication skills Track record of achievement in pharmaceutical development; able to 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 to deliver milestones according to budgets and priorities 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. 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. Relocation support available. Work Location Assignment: Hybrid. The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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. 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. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview. 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. 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. 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. Pfizer endeavors to make accessible to all users. Medical Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place. #J-18808-Ljbffr Pfizer