POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.
TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.
Location of work is remote, with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings. #Li-Remote
Reporting to the Senior Director, Quality Assurance and Quality Control, the Associate Director will have responsibilities:
- Provide quality and compliance oversight for all clinical development activities at POINT Biopharma and will perform a wide variety of activities ensuring Good Clinical Practice (GCP) compliance in accordance with applicable regulatory requirements.
- Have an in-depth understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.
- Direct and manage the internal and external GCP audit program to assure adherence to relevant FDA, EMA, ICH and other global regulations, guidelines, and procedures.
- Support vendor oversight, document management, auditing (internal and external), inspection management and Quality Agreements in a clinical setting.
- Provide QA oversight and strategic planning, coordination and continuous improvement of methods and processes to ensure the quality and integrity of clinical studies, and adherence to industry guidelines, Good Clinical Practice (GCP) and agency regulations.
- Oversee the timely generation, review, and approval of documentation within the GCP QMS.
- Provide quality oversight and support for all clinical development activities and act as a central contact for designated project communications, CAPAs, deviations, correspondences and associated essential documentation as appropriate.
- Management of clinical quality issues, investigations, and inspections.
- Management and continuous improvement of the GCP vendor quality management program and processes. Conduct audits, as needed, which will include internal, clinical investigator sites, clinical vendors, TMFs and other vendor audits to assess quality level and compliance with applicable GCP regulations and industry standards.
- Continuous evaluation over the course of a contract to ensure that a vendor meets the regulatory compliance and operational standards.
- Support Clinical during study start up and review of study plans for quality oversight.
- Schedule and track audits in accordance with approved audit plans.
- Assist in clinical trial site and vendor audit selection processes.
- Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards.
- Proactively identifies, analyzes, and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
- Create and maintain audit findings and CAPA database/tracking and analysis.
- Compile quality metrics related to clinical quality oversight, audits, and management of vendors for dissemination at meetings, as appropriate.
- Assist in the authorship and/or review of company policies, procedures, SOPs, and work instruction documents as they relate to GCP.
- Schedule and manage GCP training requirements for internal personnel.
- Maintain required knowledge and compliance of applicable regulations and government, industry, and company GCP standards and their interpretations.
- BS/BA degree in a scientific discipline required; Advanced degree preferred.
- Minimum 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 7 years of GCP-related Quality Assurance and relevant clinical trial experience, with increasing responsibility.
- Anticipate some travel may be required within North America, and will need to be able to meet current travel requirements and guidelines.
- Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
- Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
- Effective technical writing skills; able to write quality positions, audit reports, and procedures.
- Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines with an appropriate sense of urgency.
- Superior attention to detail and ability to analyze complex data.
There is no shortage of demand for smart, qualified and hardworking people like yourself - and we strongly believe POINT is the right career move for you. Here is why:
- You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
- You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
- You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
- Most importantly, you will spend everyday working on something important
If what we are saying resonates with you, please submit a cover letter and resume.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.
POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.