Manager, Global Regulatory Strategy for Oncology
3 weeks ago
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.
What You Will Achieve
You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.Liaise with and provide input/direction to Global Chemistry Manufacturing and Controls, and any other key stakeholder to ensure the filing strategies for initial registrations and the lifecycle submissions are defined and executed and the regulatory requirements are met, ensuring a submission ready dossier.Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
Qualifications
Must-Have
Bachelor's Degree5+ years of experienceDemonstrable experience of effective delivery in a complex matrix environmentRegulatory experience including knowledge of New Drug Application (NDA)/Investigational New Drug (IND) submission processesIn depth knowledge of national/regional regulatory legislation and guidelinesKnowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicineLeadership qualities and management skills, team oriented with problem solving skillsStrong written and verbal communication and interpersonal skills
Nice-to-Have
Master's degreeRelevant pharmaceutical experience
Relocation support available
Work Location Assignment: Flexible
The annual base salary for this position ranges from $99,900.00 to $166, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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 | ). 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.
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.
Regulatory Affairs
-
Executive Director, Global Development Lead
2 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARYThis position is for an Executive Director, Global Development Lead within the GU Therapeutic Area.The Global Development Lead will be responsible for defining and executing on the development strategy of Enfortumab vedotin. Reporting to the Vice President, GU Therapeutic Area Late-stage Development Head, the successful candidate should have...
-
Senior Director, Oncology Category Quality Lead
1 month ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY:Lead as a player/coach the group of Asset Quality Leaders and accountable for the management and oversight of GCP performance and quality systems within the oncology portfolio.Responsible for ensuring Level 1 GCP quality for clinical development programs within Pfizer Oncology R&D by establishing a quality framework that drives the creation and...
-
Clinical Trial Manager/Senior Clinical Trial Manager
2 months ago
La Jolla, California, United States Boundless Bio Full timeBoundless Bio (BBI), Inc. (Nasdaq:BOLD) is a San Diego-based, clinical-stage oncology company dedicated to delivering transformative therapies to patients with previously intractable oncogene amplified cancers. We are seeking a motivated and experienced Clinical Trial Manager/Senior Clinical Trial Manager who will be an essential contributor to our BBI-825...
-
Manager, Clinical Pharmacology
3 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARYWill join a team of scientists supporting oncology development programs. Will be the Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team of an oncology program.ROLE RESPONSIBILITIES Acts as Clinical Pharmacology representative on Clinical Sub Team and Development Team, as appropriate.Provides...
-
Manager, Clinical Pharmacology
2 months ago
La Jolla, California, United States Pfizer Full timePOSITION SUMMARYYou will join a team of scientists supporting oncology development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team of an oncology program.ROLE RESPONSIBILITIES Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as...
-
Vice-President, Cancer Immunology Lead
2 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY At Pfizer we deliver Breakthroughs That Change Patients Lives. Discovering new medicines at Pfizer takes teams with a diversity of skills, behaviors, and approaches. Creativity, scientific excellence, tenacity, passion, hard work, organization, teamwork, courage, open-mindedness, curiosity - are just some of the traits successful Drug...
-
Medical Director, Late Development, Prostate
3 weeks ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY This position will be responsible for supporting a late-stage clinical trial. The successful candidate should ideally have prior experience in clinical trials and supporting development programs. ROLE RESPONSIBILITIES Lead clinical study teams and ensure appropriate medical monitoring for ongoing clinical studiesLead development and maintenance...
-
Medication Services Coordinator
1 week ago
La Jolla, California, United States Integrated Oncology Network, LLC Full timeCollaborating with Healthcare Providers to Ensure Optimal Patient Outcomes Integrated Oncology Network, LLC is dedicated to supporting healthcare professionals in delivering timely and appropriate care to patients. We firmly believe that maintaining the autonomy of medical practice, where patients receive care in familiar environments surrounded by our...
-
Oncology Travel Nurse
1 week ago
La Jolla, California, United States Infojini Healthcare Full timePosition: Travel Nurse RNShift: Night 3x12-Hour (19:00 - 07:30)Overview: The ideal candidate must be available for two of the three designated holiday pairs: Christmas Eve & Christmas Day, Thanksgiving Day & the following day, and New Year's Eve & New Year's Day. A minimum of one year of experience in Oncology is required, along with six months of experience...
-
Medical Director
2 months ago
La Jolla, California, United States Boundless Bio Full timeBoundless Bio (BBI), Inc. (Nasdaq:BOLD) is a San Diego-based, clinical-stage oncology company dedicated to delivering transformative therapies to patients with previously intractable oncogene amplified cancers. Reporting to the Chief Medical Officer, we are seeking a Medical Director (Senior) who will be an essential contributor to the two clinical...
-
Senior Medical Director, Prostate Cancer
2 months ago
La Jolla, California, United States Pfizer Full timeThe Senior Medical Director provides Clinical Development leadership and expertise on clinical trials directly and/or supervises other (associate) medical directors, including overseeing study design, conduct, and analysis. The senior medical director works closely with other functions such as clinical operations, biostatistics, pharmacovigilance, regulatory...
-
Head of Clinical Pharmacology Strategy
3 days ago
La Jolla, California, United States Longboard Pharmaceuticals, Inc. Full timePosition OverviewJob Title: Director, Clinical Pharmacology & PharmacometricsReporting To: Vice President, Head of Clinical Pharmacology & PharmacometricsDepartment: R&D: ClinicalLocation: San Diego, hybrid schedule in office 3 days a weekRole SummaryThe Director of Clinical Pharmacology & Pharmacometrics will play a pivotal role within the Clinical...
-
Associate Director, Clinical Pharmacology
2 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY: You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncology programs. ROLE RESPONSIBILITIES:Serve as Clinical Pharmacology representative on Clinical Sub Team and Development...
-
Associate Director, Biostatistics
2 months ago
La Jolla, California, United States Pfizer Full timePosition is Onsite/Hybrid ROLE SUMMARY Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer standards, and best practices. Provide scientifically rigorous statistical expertise on: Projects and protocols in support of clinical development and for publication, presentation,...
-
Scientist, Tumor Biology Pharmacology
2 months ago
La Jolla, California, United States Pfizer Full timeWhat You Will Achieve We seek an accomplished Scientist level oncologist to join the in vivo Tumor Biology Translational Sciences group within Oncology Research & Development (ORD), La Jolla, California. The successful candidate will join a dynamic team of scientists and play a lead role in using models of cancer to evaluate new drug candidates, mechanisms,...
-
Associate Director, Biostatistics
1 month ago
La Jolla, California, United States Pfizer Full timeJOB SUMMARYThe Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role:Is an individual contributor role who specializes in creating...
-
La Jolla, California, United States Pfizer Full timeROLE SUMMARYThe Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological study execution ensuring consistency of approach, conduct, result reporting and oversight of core team activities within one or more specialty or primary asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs...
-
Senior Scientist, Tumor Biology Pharmacology
1 month ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARYYou will join a dynamic team of scientists in our Oncology Translational Sciences Group and play a lead role in using models of cancer to evaluate new drug candidates, mechanisms, and targets. You will participate in pre-clinical drug discovery and development programs with a focus on tumor intrinsic biology related to signal transduction,...
-
Associate Director, Clinical Pharmacology
2 months ago
La Jolla, California, United States Pfizer Full timeROLE SUMMARY:You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncologyprograms.ROLE RESPONSIBILITIES:Serve as Clinical Pharmacology representative on Clinical Sub Team and Development Team...
-
Associate Research Fellow
2 months ago
La Jolla, California, United States Pfizer Full timeExciting Opportunity: Translational Modeling and Simulation Scientist at PfizerThe Translational Modeling and Simulation Scientist will be a core member of the multidisciplinary project teams at Pfizer. They will utilize principles of quantitative translational pharmacology to guide decision making from project conception through early clinical development...
