Clinical Development Scientist, Director-Inflammation and Immunology (I&I) Non MD

Pfizer Inc.; Cambridge (MA); Ibrido; USD 177.000 - 294.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation assistance

Hybrid work arrangement

Comprehensive benefits (health, dental

Vision

Descrizione del lavoro

Pfizer Inc. in the United States is seeking a seasoned clinical development leader to coordinate and advance multiple studies for biologic and small molecule therapies across development stages.

You will drive protocol development, collaborate with Research Unit Clinicians, Global Clinical Leads, Biostatistics, Clinical Pharmacology, and Digital Medicine to ensure comprehensive I&I perspectives and timely study delivery.

Competenze

• Strong leadership for design, execution and interpretation of studies.
• Experience guiding cross-functional clinical teams.
• Excellent scientific writing and presentation skills.

Mansioni

• Provide scientific leadership for trial design, execution and interpretation.
• Lead development programs and work independently within project teams.
• Serve as a technical resource for clinical issues among collaborators and contractors.
• Support publications, abstracts and scientific communications.
• Participate on project teams to meet startup, conduct and closeout milestones.
• Lead preparation of protocols and key documents (ICFs, SAPs, regulator documents).
• Lead data review activities and analyze safety and efficacy data.

Conoscenze

Clinical leadership

Cross-functional collaboration

Scientific communication

Formazione

PhD/PharmD

MS

BSc

Descrizione del lavoro

POSITION SUMMARY

You will lead and coordinate the development of multiple clinical studies for novel biologic and small molecule therapies across various stages of clinical development within a given therapeutic area.

You will lead clinical protocol development and participate as an individual contributor on clinical study teams to support enrollment and study delivery timelines. You will work closely with cross-functional partners to ensure the full scope and perspective of I&I are represented within clinical study teams, including Research Unit Clinicians, Global Clinical Leads/Medical Monitors, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine.

You will contribute to clinical drug development activities across the development continuum and serve as a key member of clinical sub-teams to ensure collaboration and seamless connectivity across functions.

POSITION RESPONSIBILITIES

• Provide scientific leadership for the design, execution, and interpretation of clinical studies, delivering innovative study designs, high-quality trial execution, safety assessments, and clinically meaningful study outcomes.
• Lead and support the development and execution of clinical development programs, operating independently within project teams.
• Serve as a technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors.
• Support the development of publications, abstracts, presentations, and scientific communications.
• Participate on project teams to support clinical development strategy, study implementation, and achievement of key development milestones, including the startup, conduct, and delivery of clinical studies.
• Lead preparation of clinical protocols and lead or contribute to other key study documents, including informed consent forms, study training materials, investigator brochures, statistical analysis plans, and regulatory documents.
• Lead clinical data review activities, including the collection, analysis, and interpretation of safety and efficacy data for safety review meetings and ongoing data review activities conducted in accordance with data review plans.
• Collaborate with study teams to maintain open and transparent communication and support successful study execution and completion.
• Foster a transparent environment that encourages strong partnerships and mutual trust across teams, sub-teams, and therapeutic areas.
• Develop effective partnerships with project leaders and cross-functional colleagues across Pfizer, including Biostatistics, Regulatory Affairs, Clinical Pharmacology, Clinical Operations, and other relevant functions.
• Be accountable to multiple project teams, core study teams, and clinical sub-teams while effectively managing priorities to support the startup, conduct, and closeout of clinical studies.
• Develop expertise in Pfizer clinical processes, checklists, and Standard Operating Procedures (SOPs) to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, Institutional Review Boards (IRBs), and Pfizer standards. Apply learnings to support continuous process improvement within the I&I organization.
• Develop expertise in Pfizer compliance systems, registries (e.g., GDMS, pTMF, Clinical Trial Registries), and other study systems (e.g., CORD, JReview, Signal Management), and apply lessons learned to improve study execution across the I&I organization.
• Partner with relevant functional lines to ensure biomarker strategies are incorporated into therapeutic area programs to support patient stratification, efficacy assessments, and clinical development objectives.
• Establish and maintain relationships with external experts, consultants, key opinion leaders (KOLs), regulators, and disease-specific investigator networks to ensure that evolving scientific and clinical insights are appropriately incorporated into development plans and study designs and to support study conduct, data interpretation, and dissemination of results.
• Maintain current knowledge of scientific and clinical literature relevant to I&I therapeutic areas and associated clinical development strategies.

MINIMUM QUALIFICATIONS

• PhD/PharmD and 5+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones OR
• MS and 7+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones OR
• BSc and 8+ years of relevant industry experience in clinical development, clinical research, or a related drug development role, with a demonstrated track record of supporting development programs through key milestones.
• Deep understanding of the biopharmaceutical environment and clinical drug development, with familiarity across related disciplines including Biostatistics, Regulatory Affairs, Clinical Pharmacology, and Pharmaceutical Sciences.
• Experience developing and coaching others, guiding cross-functional teams, and driving meaningful business impact.
• Strong scientific writing, presentation, and verbal communication skills.
• Experience building consensus, influencing stakeholders, and driving change across all levels of the organization, including senior leadership.
• Strong experience reviewing clinical data listings and interpreting study data.

PREFERRED QUALIFICATIONS

• Experience in Immunology clinical development
• Experience supporting Phase 2, Phase 3, and/or late-stage clinical development programs
• 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.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional Travel 5-10%
• Relocation support available
• Work Location Assignment: Hybrid--Will work on-site an average of 2.5 days per week and must be commutable to the site.

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Candidates must be authorized to be employed in the U.S. by any employer.

Relocation assistance may be available based on business needs and/or eligibility.

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.

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 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 EligibilityPfizer 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.

Medical