Clinical Development Scientist, Senior Manager

Regulatory Toolkit; Cambridge (MA); Hybrid; USD 139.000 - 232.000; Vollzeit

Benefits dieser Stelle

401(k) plan with Pfizer Matching

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Paid caregiver/parental and medical-le

Health benefits

Zusammenfassung

Pfizer seeks an experienced Senior Manager to provide scientific and clinical oversight of clinical trials in the Inflammation & Immunology portfolio. As an individual contributor, you ensure data integrity and quality across early and late-stage development, aligning with the development strategy.

You will partner with clinical, medical, operations and regulatory teams to execute trials with high scientific and ethical standards.

Qualifikationen

• PhD/PharmD with 2+ years of relevant experience in clinical research.
• MS with 5+ years of relevant experience in clinical research.
• Experience in clinical development within the pharmaceutical/biotechnology industry.
• Knowledge of ICH guidelines and Good Clinical Practice (GCP).
• Excellent scientific writing and strong verbal communication skills.

Aufgaben

• Maintains current scientific and clinical knowledge in assigned therapeutic areas.
• Authors and reviews clinical/regulatory documents (protocols, ICFs, IBs, CSRs).
• Leads the clinical data review strategy and presents data to stakeholders.
• Collaborates across Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Pharmacology.
• Provides input for site training materials and responds to investigator questions.
• Ensures compliance with SOPs, regulations, and GCP; seeks quality improvements.

Ausbildung

PhD

PharmD

MS

Jobbeschreibung

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs.

The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality.

JOB RESPONSIBILITIES

• Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components.
• Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders.
• Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly.
• Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.
• Ensures compliance with relevant SOPs, regulations, and Good Clinical Practice (GCP); seeks opportunities to improve quality and efficiency of clinical development procedures and may participate in process improvement workgroups.
• Contributes to the preparation for Health Authority meetings and may participate as appropriate.
• May mentor junior team members.

QUALIFICATIONS / SKILLS

• Advanced degree (PhD, PharmD, MS) in a relevant scientific discipline is required. This is a non-MD role.
• Experience requirements:
  • PhD/PharmD with 2+ years of relevant experience in clinical research.
  • or MS with 5+ years of relevant experience in clinical research.
• Demonstrated experience in clinical development within the pharmaceutical/biotechnology industry is required.
• Experience in the Inflammation & Immunology (I&I) therapeutic area is preferred but not required.
• Strong understanding of the drug development process, clinical trial design, and execution.
• Excellent knowledge of clinical procedures, ICH guidelines, and Good Clinical Practice (GCP).
• Proven scientific writing skills and strong verbal communication skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
• Strong analytical, organizational, and project management skills with the ability to manage multiple projects and priorities.

Work Location Assignment:This is a Hybrid that requires candidates to commute on time an average of two days a week

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.

• 401(k) plan with Pfizer Matching Contributions
• 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

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.

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

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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.

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