Senior Manager, Oncology Early Stage Clinical Scientist
- United States - California - La Jolla
- United States - Washington – Bothell
- United States - Connecticut - Groton
- United States - California - South San Francisco
- United States - Pennsylvania - Collegeville
- United States - New York - New York City
ROLE SUMMARY:
The Senior Manager, Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development Lead (and members of the development team) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or more novel biological or small molecule therapies, spanning first in human (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies.
You will work with other functional disciplines (e.g., Clinical Operations, Biostatistics/Data Management, Clinical Pharmacology, Translational Oncology, and Biomarkers) to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as needed within clinical study teams.
You will also be mentored/obtain guidance from a more senior study clinician. Depending on experience, you may lead the development of the clinical protocol and may participate as an individual contributor on clinical study teams and clinical sub teams to meet enrollment and study delivery timelines.
ROLE RESPONSIBILITIES:
Primary responsibilities in supporting the GDL in the execution of the clinical development strategy and plan for the assigned molecule(s)/indications(s).
Depending on experience, may lead the preparation of clinical protocol and may leads or supports other critical documents, e.g., protocol amendments, investigator brochure, and regulatory documents.
Together with Clinical Operations, is responsible for timely execution of all FIH programs through proof-of concept and delivering on innovative clinical study designs, high quality trial execution with Oncology Research Development (ORD), safety assessment and interpretation of clinical study results.
Conducts data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics.
In accordance with the Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead (or his/her delegate) and the GDL.
May support the transition early development clinical programs into late stage development, as appropriate.
In conjunction with members of the development team, may prepare presentations regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
Supports and assists in the development of publications, abstracts, and presentations.
May interface with safety sciences, statistics, PK/PD, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators in such a way as to foster a transparent environment that encourages strong partnerships and mutual trust.
Supports the GDL and senior clinical scientist, in developing effective collaborations with project leaders and project team members.
Partners with Translational Oncology and Biomarkers as needed to ensure that biomarker plans to help determine early signs of efficacy and proof of concept, patient stratification, etc. are enabled.
In conjunction with the GDL and senior study clinician, may establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results.
Performs other duties as assigned related to clinical programs
QUALIFICATIONS:
PhD/PharmD and 2+ years experience in a clinical scientist type role
MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
BA/BS/BSN and 7+ years of experience in clinical development including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
Experience in Oncology drug development especially in Early Development
Familiarity with related disciplines (Biostatistics, Regulatory, Pre-Clinical Pharmacology, Pharmaceutical Sciences)
Proven scientific writing skills and strong communication skills
Demonstrated experience with GCP and (the ability to apply Pfizer policies and SOPs)
Experience building consensus and driving change across all levels of the organization including senior management.
Data listing review experience
Experience working collaboratively in a fast-paced, team-based matrix environment as well as independently
Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
PREFERRED QUALIFICATION:
Experience applying Pfizer policies and SOPs
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
5-10% Travel
Work Location Assignment: Site Based Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
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Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)