(Senior) Clinical Scientist

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.

Reporting into the Executive Vice President of Clinical, the Senior Clinical Scientist will provide support and collaborate with the clinical development team. They will provide scientific expertise to clinical programs programs and work with clinical operations, biometrics and other stakeholders

Your responsibilities will include:

• Participate in the development, review and management of clinical protocols, study manuals, ICFs, IBs, DMCs, study tools and other essential documents
• Serve as a key clinical contributor for CRF development and vendor data collection questions (e.g. lab imaging)
• Engage with investigators, site staff, CROs and site monitors to serve as protocol SME and to support enrollment for ongoing clinical studies
• Monitor, review and analyze data to identify trends, inconsistencies and follow up as appropriate
• Develop slides and train study team members on various topics including but not limited to product details, therapeutic, indication, literature
• Participate in the planning and execution of investigator meeting and site initiation visits
• Support the selection of participants, development of content and execution of Advisory Board Meetings
• Ensure clinical trial data is collected according to the protocol specifications and clinical intent
• Contribute to abstract and manuscript writing
• Manage clinicaltrials.gov content and requirements
• Establish SOPs on the creation and review of documents and authorship of manuscripts

Requirements

• Pharm D, MPH/MS, PhD or MD
• 5 +years of relevant working experience in pharmaceutical/biotech
• Oncology, Radiopharmaceutical required preferred
• Clinical/Medical writing experience preferred
• Experience in principles of clinical trial methodology, statistics, data analysis and interpretation
• Understanding of GCP/ICH, FDA regulations and guidelines
• Clinical SOP knowledge

Benefits

Why joining POINT today will be the right career move for you:

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.