Clinical Development Medical Senior Director (MD Required) (Groton)

The Clinical Development Medical Senior Director is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies, leading and contributing to process improvement initiatives. They may also manage, supervise, and mentor others.JOB RESPONSIBILITIESProvides medical monitoring on one or more clinical trials:Provides timely, study-related medical information and guidance, e.g., on:Medical questions from investigator sitesMedical issues in clinical trial dataMedical findings in audits or inspectionsContributes to medical assessments of Quality EventsConducts and documents periodic safety data review and ongoing clinical/medical data reviewReviews Required Safety Text for the Informed Consent Document and significant medical changes in the Informed Consent DocumentMay independently lead clinical execution of one or more studies; accountable for program level clinical deliverablesProvides input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator LettersRepresents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactionsEnsures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requestsProvides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and FiguresProvides clinical guidance 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; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents 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 guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narrativesProvides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigationsEstablishes and manages External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, provision and presentation of data, and documentation and dissemination of Committee recommendationsDevelops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleaguesParticipates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality eventsServes as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends reviewEnsures TMF compliance for clinical documentsProvides clinical input and review of the Clinical Study ReportEnsures 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)Leads the adoption and implementation of continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution at the program and portfolio levels; contributes to enterprise-level initiativesMay have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop othersBASIC QUALIFICATIONSAs 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.PREFERRED QUALIFICATIONSCardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc. Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority.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 presentationsExtensive knowledge of clinical development, global and regional regulation, and ICH/GCPClinical, administrative, and project management capabilities; effective verbal and written communication skillsExperience launching, managing, and training clinical development teamsTrack record of achievement in pharmaceutical development; able to coordinate and 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 and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities; able to define and manage resource requirementsEffective 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 changeNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSGlobal travel may be requiredWork 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
The annual base salary for this position ranges from $274,500.00 to $457,500.00. 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.

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 ActPfizer 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 recrui]]> <