Oncology Late Stage Clinical Development Scientist (Non MD)-Multiple Openings- Director

140 Pfizer Inc; New York (NY); Hybrid; USD 177,000 - 294,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching Contribu­t

Pfizer Retirement Savings Contribution

Paid vacation, holidays and personal

Health benefits: medical, dental, viz

Job summary

Pfizer Inc. is seeking a senior clinical development expert to oversee scientific integrity, data quality, and regulatory readiness for late-stage oncology programs. You will lead cross-functional collaboration, author essential trial documents, and drive data review strategies across pivotal trials.

Candidates should have deep clinical research experience, oncology expertise, and a proven track record in regulatory submissions and inspections within industry/CRO settings. Hybrid on-site role.

Qualifications

• PhD/Pharm D or MS/BA with extensive Clinical Research experience in industry/CRO.
• Experience in phase 3/pivotal Oncology trials, regulatory submissions and inspections.
• Strong knowledge of ICH, GCP and global regulatory requirements.

Responsibilities

• Provide scientific oversight, data integrity and quality for clinical trials in oncology programs.
• Partner with cross-functional teams to execute trials and implement development strategies.
• Represent the study team in governance meetings and support regulatory submissions.
• Author study documents and contribute to clinical study reports and regulatory responses.
• Set data review strategy and lead quality data collection and trend analysis.
• Monitor emerging safety data and keep medical/clinical teams informed of changes.
• Ensure compliance with SOPs, regulations and quality standards; drive process improvements.

Skills

Clinical Research

ICH guidelines

GCP

Regulatory knowledge

Data interpretation

Scientific communication

Education

PhD/Pharm D in a relevant Science discipline

MS in a relevant Science discipline

BA/BS in a relevant Science discipline

Tools

Microsoft Office

Job description

POSITION SUMMARY

POSITION SUMMARY You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.

KEY RESPONSIBILITIES

• Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Effectively partner 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.
• Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
• Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
• Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
• Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
• Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

MINIMUM QUALIFICATIONS

PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Solid tumor or hematology clinical trial experience Experience leading a team Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery Experience leveraging a variety of communication tools and techniques to communicate results Experience solving problems collaboratively and handling conflict constructively Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience working proactively and independently, organizing tasks, time and priorities of self and others Experience building partnerships across the company to achieve the needs of the program.

COMPETENCIES FOR SUCCESS

Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Demonstrates foresight and judgment to make complex decisions Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. both as a leader and a key contributor 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.

Work 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. 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 [e-mail]. 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 Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.