Clinical Development Scientist, Senior Manager

Pfizer; United States; Hybrid; USD 139.000 - 232.000; Vollzeit

Zusammenfassung

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

You will partner with Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Pharmacology to execute trials with high scientific and ethical standards.

Qualifikationen

• PhD/PharmD with 2+ years of clinical research experience.
• MS with 5+ years of clinical research experience.
• 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.

Aufgaben

• 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.

Kenntnisse

Advanced degree

Clinical research experience

Pharma/biotech industry

ICH/GCP knowledge

Scientific writing

Team collaboration

Project management

Data interpretation

Ausbildung

PhD/PharmD/MS

MS with 5+ years experience

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. 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.

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