Taiho Oncology, Inc.
Associate Director, PV Sciences
Taiho Oncology, Inc., Pleasanton, California, United States, 94566
Associate Director, PV Sciences
– Taiho Oncology, Inc.
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting‑edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world‑class clinical development organization, and state‑of‑the‑art facilities empower us to innovate and touch the lives of more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Hybrid Hybrid
Employee Value Proposition Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. As an integral part of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide. With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally.
Position Summary The Associate Director, PV Sciences will lead medical surveillance activities for assigned products in collaboration with the Medical Surveillance Physician. The incumbent is expected to work cross‑functionally with key internal and external stakeholders, and resources on pharmacovigilance‑related matters.
Performance Objectives
Lead aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products.
Support Medical Surveillance Physicians in product benefit‑risk assessment and related activities.
Collaborate with Medical Surveillance Physicians in ad‑hoc and routine GSMT meetings.
Lead signal management activities with the PV team.
Lead development/maintenance of Risk Management Plans (RMP) and associated PV and risk‑minimization activities.
Participate in new study initiation to ensure PV requirements are met, including safety reporting, query resolution, SAE reconciliation, unblinding process, and safety reporting training.
Review protocols, informed consents, company core data sheets, investigator brochures, clinical summaries of NDA/MAA, product labeling and other clinical trial documents.
Evaluate current processes, propose and implement improvements to enhance medical surveillance and risk‑management processes.
Oversee and manage review and approval of Safety Reporting Plans as applicable.
Develop or update SOPs, working instructions, and training materials as needed.
Collaborate with internal and external stakeholders outside Taiho (e.g., business partners).
Ensure compliance with regulatory submissions and internal timelines.
Participate in audit‑preparation activities and serve as subject‑matter expert during regulatory inspections.
Maintain training and oversight of clinical operations/pharmacovigilance vendors.
Support additional PV Sciences activities as requested by the supervisor.
Education / Certification Requirements Bachelor’s degree in health‑care related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred.
Knowledge, Skills, and Abilities
8–10 years of progressively responsible pharmacovigilance experience in pharma, biotech, or related environment.
Proficiency in signal detection, safety surveillance, risk mitigation and risk management.
Experience directly managing people or leading cross‑functional teams (plus).
Expertise with FDA, EU, and ICH guidelines governing pharmacovigilance.
Extensive knowledge of MedDRA.
Hands‑on experience improving departmental processes to increase efficiency and quality.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast‑paced matrixed team.
Excellent planning, organization, and time‑management skills.
Ability to influence without direct authority.
Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedures.
Ability to present information and respond to questions from internal and external clients.
Comfort with mathematical concepts such as probability, statistical inference, fractions, percentages, ratios, and proportions.
Analytical thinker with strong problem‑solving skills and ability to adapt to changing priorities and deadlines.
Pay Range: $192,950 – $227,000 annually. The total compensation package may include an annual bonus/incentive plan, long‑term incentive plan, and discretionary awards, plus benefits such as 401(k) eligibility, paid time off, vacation, sick time, and parental leave.
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. We provide reasonable accommodations for applicants and employees with disabilities. We consider qualified applicants with arrest and conviction records under applicable Fair Chance Laws and Ordinances.
The incumbent in this position may be required to perform other duties, as assigned.
#J-18808-Ljbffr
– Taiho Oncology, Inc.
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting‑edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world‑class clinical development organization, and state‑of‑the‑art facilities empower us to innovate and touch the lives of more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Hybrid Hybrid
Employee Value Proposition Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. As an integral part of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide. With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally.
Position Summary The Associate Director, PV Sciences will lead medical surveillance activities for assigned products in collaboration with the Medical Surveillance Physician. The incumbent is expected to work cross‑functionally with key internal and external stakeholders, and resources on pharmacovigilance‑related matters.
Performance Objectives
Lead aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products.
Support Medical Surveillance Physicians in product benefit‑risk assessment and related activities.
Collaborate with Medical Surveillance Physicians in ad‑hoc and routine GSMT meetings.
Lead signal management activities with the PV team.
Lead development/maintenance of Risk Management Plans (RMP) and associated PV and risk‑minimization activities.
Participate in new study initiation to ensure PV requirements are met, including safety reporting, query resolution, SAE reconciliation, unblinding process, and safety reporting training.
Review protocols, informed consents, company core data sheets, investigator brochures, clinical summaries of NDA/MAA, product labeling and other clinical trial documents.
Evaluate current processes, propose and implement improvements to enhance medical surveillance and risk‑management processes.
Oversee and manage review and approval of Safety Reporting Plans as applicable.
Develop or update SOPs, working instructions, and training materials as needed.
Collaborate with internal and external stakeholders outside Taiho (e.g., business partners).
Ensure compliance with regulatory submissions and internal timelines.
Participate in audit‑preparation activities and serve as subject‑matter expert during regulatory inspections.
Maintain training and oversight of clinical operations/pharmacovigilance vendors.
Support additional PV Sciences activities as requested by the supervisor.
Education / Certification Requirements Bachelor’s degree in health‑care related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred.
Knowledge, Skills, and Abilities
8–10 years of progressively responsible pharmacovigilance experience in pharma, biotech, or related environment.
Proficiency in signal detection, safety surveillance, risk mitigation and risk management.
Experience directly managing people or leading cross‑functional teams (plus).
Expertise with FDA, EU, and ICH guidelines governing pharmacovigilance.
Extensive knowledge of MedDRA.
Hands‑on experience improving departmental processes to increase efficiency and quality.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively in a fast‑paced matrixed team.
Excellent planning, organization, and time‑management skills.
Ability to influence without direct authority.
Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedures.
Ability to present information and respond to questions from internal and external clients.
Comfort with mathematical concepts such as probability, statistical inference, fractions, percentages, ratios, and proportions.
Analytical thinker with strong problem‑solving skills and ability to adapt to changing priorities and deadlines.
Pay Range: $192,950 – $227,000 annually. The total compensation package may include an annual bonus/incentive plan, long‑term incentive plan, and discretionary awards, plus benefits such as 401(k) eligibility, paid time off, vacation, sick time, and parental leave.
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. We provide reasonable accommodations for applicants and employees with disabilities. We consider qualified applicants with arrest and conviction records under applicable Fair Chance Laws and Ordinances.
The incumbent in this position may be required to perform other duties, as assigned.
#J-18808-Ljbffr