Clinical Development Scientist, Senior Manager

Pfizer · Cambridge, MA · 2 days ago

$139k–$232k/yrFull-time

We need to output HTML fragment with sections: About the role? Not present. Responsibilities: list of duties. Requirements: maybe Basic Qualifications and Preferred Qualifications. Benefits: described. Pay: salary range. Schedule: hybrid schedule info. Also maybe Work Location Assignment. Should not repeat job title. No boilerplate like EEO, legal, etc. Remove duplicated lines. Must preserve all substantive info. We need to decide sections: Responsibilities (list), Qualifications (maybe combine Basic and Preferred), Benefits, Pay, Schedule. Also maybe "Work Location" but not required heading; could be part of Schedule or separate? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use Qualifications heading for both basic and preferred. Could also have Skills but not needed. We must not create sections with filler like "commensurate with experience". We have actual content. We need to output only HTML fragment, no /, no markdown fences. Let's extract responsibilities list: many bullet-like sentences separated by semicolons. We'll convert each to

. Probably each sentence after "Job Responsibilities" is a responsibility. We'll split by semicolons? Better to treat each line starting with a capital verb as separate item. The text after "Job Responsibilities" is a long paragraph with many sentences separated by semicolons and periods. We'll break at each semicolon and period that ends a sentence. But to keep it simple, we can create

using the sentences as they appear, preserving content. We'll need to ensure we don't lose any info. Let's copy the responsibilities text: "Provides clinical support for one or more studies; may be accountable for program level clinical deliverablesMay provide input to the protocol design document; contributes to development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator LettersSupports 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 interactionsMay develop Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requestsProvides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and FiguresProvides 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 lockProvides 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 narrativesProvides 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 mitigationsSupports 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 recommendationsContributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleaguesParticipates 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 eventsMay 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 reviewEnsures TMF compliance for clinical documentsProvides clinical input and review of the Clinical Study ReportProvides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to publicationsProvides clinical support to audits and inspections, including responding to and addressing audit and inspection findingsMay 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 executionMay supervise, mentor, or develop others" We need to split into items. Could just wrap the whole paragraph in
but instruction says use
- for any list of duties/requirements/benefits. So we need list. We can split by semicolons that are followed by a capital letter (or by "May" etc). Might be messy but we can approximate. Better: create
  - . Let's manually identify sentences: 1. Provides clinical support for one or more studies; may be accountable for program level clinical deliverables 2. 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 3. 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 4. May develop Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests 5. Provides clinical input to the development of the Statistical Analysis Plan and Tables, Listings, and Figures 6. 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 7. 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 8. 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 9. 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 10. Contributes to site selection criteria, provides clinical input to selection of sites, and may deliver protocol training to site-facing colleagues 11. 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 12. 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) 13. 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 14. Ensures TMF compliance for clinical documents 15. Provides clinical input and review of the Clinical Study Report 16. Provides clinical support to disclosure of safety and efficacy data and trial conclusions; may contribute to publications 17. Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings 18. 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) 19. Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution 20. May supervise, mentor, or develop others That seems comprehensive. Now 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 list: many bullet-like sentences separated by line breaks? The text: "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 inspectionsScientific productivity via publications, posters, abstracts and/or presentationsKnowledge of clinical development, global and regional regulation, and ICH/GCPClinical and administrative capabilities; effective verbal and written communication skillsTrack record of achievement in pharmaceutical development; able to execute clinical development during design, start-up, conduct, close-out, and reportingUnderstands the complexities and recent developments in the principal disease areas; competent discussing scientific and regulatory aspects of drug developmentAble to set priorities to deliver milestones according to budgets and prioritiesEffective leader; able to mentor/coach, delegate to, and oversee others; able to develop others’ skills and move them toward autonomyAble to resolve conflicts equitably; fosters open dialogue; addresses conflicts; reads situations quickly; negotiates agreements; escalates issues when appropriate; takes responsibility for decisionsShares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belongingTakes personal responsibility for delivery of resultsAble to demonstrate perspective and poise in uncertainty and organizational change" We need to split into list items. Let's separate by periods where each starts with a capital letter (or after a period). We'll create items: - 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 Now Benefits: "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." We can make list: 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. Pay: "The annual base salary for this

Clinical Development Scientist, Senior Manager

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