Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.
The Director, Pharmacovigilance Operations is a highly visible role that will require a collaborative attitude, an authentic and ‘hands-on’ approach, as well as a strong strategic vision. You will enjoy sharing your knowledge and communicating a clear vision among team members. You will need to be able to effectively align resources to achieve functional area goals in alignment with corporate goals.
This position is instrumental and of significant impact to the company. You will need to be creative and a strategic thinker and will serve as the SME in cross-functional teams. You will be accountable for the successful strategy, oversight, and execution of deliverables for the case management team, and ensuring individual adverse event case reports from all sources are collected, managed and reported according to Candel’s SOPs and global adverse event regulations and guidelines. We are on a critical mission to bring quality solutions to patients. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
- Oversee and manage all operational aspects of drug safety and pharmacovigilance.
- Manage contract PV service providers and ensure appropriate documentation is in place to support activities, including aggregate report production and compliance with timely reporting of safety information to Regulatory Authorities to meet regulatory requirements.
- Provide leadership and direction on the development of best practices and processes.
- Ensure compliance with world-wide Health Authority regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
- Provide direction and leadership regarding safety vendor management.
- Facilitate cross functional safety reviews with study physician team member.
- Participate in the writing of aggregate safety reports including DSURs
- Provide subject matter expertise for regulatory submissions and collaborations with cross-functional areas as appropriate.
- In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities, maintain, and update regulatory reporting rules, ensure timely submission of expedited safety reports, and ensure that submission information is tracked in the safety database.
- Develop SOPs, provide operational input into existing SOPs to execute best pharmacovigilance practices to maintain compliance with regulations and protect patient health.
- Ensure SAE reconciliation is done in collaboration with data management, Candel team and vendors as required.
- Identify opportunities for process efficiencies and participate in process improvement initiatives.
- Identify PV service vendor staff training needs and opportunities for improvement and ensure implementation in collaboration with Candel stakeholders.
- Act as liaison between PV service provider and appropriate Candel departments to ensure access to Candel safety database and resolve any technical issues.
- Bachelor’s degree in the life sciences or related area, Master’s degree or higher preferred.
- Minimum 8 years of experience with a demonstrated focus in PV operations and compliance.
- Hands-on experience with validated safety database, such as Argus, Aris-G or Veeva Safety.
- Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
- Thorough knowledge of pharmacovigilance regulations in US (CFR) and Europe (GVP)
- Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review, and regulatory submission, issuing follow up queries, etc.
- Excellent written and verbal skills; ability to translate and communicate complex information and concepts.
- You have a thirst for learning. You relish in sharing knowledge and know how to have fun doing so!
- You are comfortable taking risks and (appropriately) pushing boundaries.
- You build genuine relationships. You trust your co-workers. You truly enjoy working together and understand we are all more successful when we work as a team.
A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large. Please visit www.candeltx.com for more information.
We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology. For consideration, please submit CV.
Interested candidates please submit your resume to email@example.com