Role at a glance
- Job function
-
Engineering & R&D Biotechnology & Pharmaceutical R&D
- Salary
- Not yet verified Check the description for pay details; an amount or pay period has not been verified.
- Location
- Cambridge, Massachusetts, United States
- Work arrangement
- Hybrid
- Employment
- Full-time
- Experience
- 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.
- Education
- PhD/PharmD and 5+ years of relevant industry experience in clinical development, clinical research, or a related drug development role,...
- Visa support
- 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...
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Role Summary
Leads and coordinates development of multiple clinical studies for novel biologic and small-molecule therapies across stages of clinical development in Inflammation and Immunology. The role provides scientific leadership for study design, execution, and interpretation while coordinating with cross-functional partners and external experts.
What You'll Do
- Lead clinical protocol development and contribute to other study and regulatory documents.
- Provide scientific leadership for study design, execution, safety assessments, and interpretation of clinical data.
- Support clinical development programs and study implementation, including study startup, conduct, and closeout.
- Coordinate with cross-functional teams and external experts to support study execution, biomarker strategies, and interpretation of results.
- Support development of publications, abstracts, presentations, and scientific communications.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires relevant industry experience in clinical development, clinical research, or related drug development; a demonstrated track record supporting development programs through key milestones; understanding of biopharmaceutical development and related disciplines; experience developing and coaching others and guiding cross-functional teams; strong scientific writing, presentation, and verbal communication skills; consensus-building and stakeholder-influencing ability; and experience reviewing clinical data listings and interpreting study data.
Preferred
- Experience in Immunology clinical development
- Experience supporting Phase 2, Phase 3, and/or late-stage clinical development programs
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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. 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 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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
About the company
Pfizer
Large Enterprise
Pfizer is a global biopharmaceutical company dedicated to the discovery, development, and manufacturing of innovative healthcare solutions. With a strong focus on improving lives through medications and vaccines, Pfizer has played a significant role in addressing various health challenges, including infectious diseases, chronic illnesses, and rare conditions. The company emphasizes research-driven approaches and collaborative efforts in its mission to enhance global health and empower patients through cutting-edge science and technology. Through its commitment to high standards of safety and efficacy, Pfizer continues to shape the future of medicine.