Job title: Director, Safety and Risk Management
Company: Infinity Pharmaceuticals
Job description: We are a passionate, fun, and innovative team dedicated to advancing novel medicines for people with cancer. We are developing eganelisib (IPI-549), a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which is designed to address a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies. Because of encouraging data from our clinical program to date, we are actively designing a registration-enabling, randomized study in first-line metastatic triple-negative breast cancer. We are also in the process of identifying other solid tumor indications for exploratory studies, including a potential platform study (MARIO-P) to test novel eganelisib combinations. We have completed enrollment and are following patients in the following studies: * MARIO-3 is evaluating eganelisib in combination with Tecentriq® and Abraxane® in frontline TNBC and in combination with Tecentriq and Avastin® in frontline RCC.
- MARIO-275, a randomized, controlled combination study of eganelisib combined with Opdivo® (nivolumab) in I/O naïve urothelial cancer.
- MARIO-1, the first in-human Phase 1/1b study of eganelisib in patients with advanced solid tumors.
The successful candidate will report to the Chief Medical Officer and serve as the expert for the team in the management of safety signal, risk management activities, and benefit risk assessments for eganelisib. The individual will have demonstrated accountability and a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders either verbally or in writing with impact.
- Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities.
- Leads PV, Safety and Risk Management department and the people within it, including FTEs, consultants, and contractors.
- Oversee safety operations activities that are outsourced to a 3rd party CRO to ensure individual case safety reports are completed with the highest quality and reported to appropriate stakeholders while maintaining compliance with regulatory and safety data exchange requirements.
- Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity, and completeness of safety information, and to ensure consistency of medical coding of safety data.
- Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools, leading quarterly safety review meetings, and reviewing other sources of potential product signals (ie. literature review).
- Ensure ongoing evaluation of the overall safety profile for eganelisib, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
- Support the Clinical Operations group with respect to safety related issues as required.
- Represent the Safety function on study and program level teams
- Provide input and review of responses to regulatory agency questions regarding safety/ pharmacovigilance activities.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports and final study reports, and other documents as needed
- Lead, with the support and input of the cross-functional product team the development and/or update of the IB, DSUR and other documents, as needed.
- Assess global PV requirements for resources, equipment, and systems to maximize efficiency.
- Support development and maintenance of product benefit-risk profile including planning for activities required in a post marketing setting
- Collaborate cross-functionally on review of investigator-initiated trials, single patient INDs and expanded access initiatives, as applicable
- Medical or relevant advanced degree strongly preferred.
- 7+ years’ relevant industry experience in drug safety, including experience in oncology/immunotherapy.
- Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management).
- Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments.
- Ability to work well independently and to organize priorities and deliverables.
- Ability to work under pressure in aggressive timelines including as a part of a cross-functional team.
- Strong oral and written communication skills, including ability to present to the senior management and external audiences and experts.
- Good leadership and management skills to manage internal and external collaborations.
What’s it like to work with us? We believe that the energy of our culture and wellbeing of our team drives the passion behind our work. So, here’s how we cultivate our culture and wellbeing:
- We’ve got you covered:
- Medical (PPO) and Dental coverage offered through BCBS with 100% premium covered by Infinity as well as vision plan offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Health Savings Accounts with company contribution
- Other insurance protections paid by Infinity, including: life insurance, short-term and long-term disability
- Balancing work and life:
- A four-week paid sabbatical every five years with us
- Summer Friday hours
- 12 paid holidays and Summer (week of July 4th) and Winter (between Christmas and New Year’s Day) shutdowns
- 20 vacation days
- Hybrid work schedule
- Competitive compensation and financial support:
- Competitive base salary, annual merit-based cash bonus program, and stock option program
- 401(k) plan with 100% company match on first 6% deferred, vested immediately
- First-time Homebuyer Assistance Program
- Subsidized parking or T/Commuter Rail pass
- Voluntary auto/home Insurance discounts, Bluebikes discounts, employee assistance program, legal assistance program
- Tuition Reimbursement Program
- We like to eat: You’ll find a nicely stocked kitchen, weekly catered lunches, and happy hour socials, as well as offsites centered around good food
- We like to play: Social and team-building events are planned throughout the year
Location: Cambridge, MA
Job date: Sat, 16 Jul 2022 04:04:07 GMT
Apply for the job now!