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
The position will be working remotely 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.Overview
Reporting to the Director, Clinical Operations the Associate Director, Clinical Program Manager- Late Phase is responsible for the day-to-day management and overall operations of late phase clinical trials in close collaboration with cross-functional teams and through oversight and management of vendors conducting company sponsored trials.
- Manage the successful conduct of assigned clinical trial(s) and provide operational leadership within an outsourced model
- Provide operational oversight of contracted vendor partners, to ensure effective execution of trials under assigned program, ensuring high quality on-time and on-budget delivery of assigned project/program
- Contribute to study design initiatives as well as trial level documents within assigned program and in collaboration with Clinical Operations, Medical Affairs, Pharmacovigilance, Data Management and Clinical Development
- Manage and coordinate the evaluation, selection and assessment of outsourced vendors
- Oversee the management and monitor the day-to-day activities selected vendors
- Develop and manage program level and/or project level timelines, budget and milestones
- Generate reports to ensure succinct updates to leadership on project/program progress
- Develop key quality metrics and determine appropriate action in conjunction with study team
- Perform review of vendor invoices to ensure that work is performed in accordance with scope
- Function as primary contact both internally and externally
- Accountable for on time delivery of trials, within budget and with the highest achievable quality
- Accountable for the translation of the Clinical Development Plan into effective operational strategy and provide overall assessment of various operational scenarios for optional execution
- Collaborate with vendor partners to ensure patient enrollment and high-quality data collection are in accordance with trial and corporate objectives, and escalation of risk to timelines as needed
- Contribute to the development of high-quality study documents including but not limited to Study Protocols, eCRF designs, completion guidelines, study manuals, ICFs and other study related materials.
- Maintain close communication with Director, Clinical Operations to ensure program level expectations and activities are aligned
- Develop and lead late phase project/program operational strategy and planning in close collaboration with cross-functional teams and assigned vendors
- Perform oversight of vendor partners to ensure the operational execution and delivery of assigned clinical program in compliance with quality standards (including ICH, GCP, local regulations and POINT Biopharma SOPS)
- Collaborate with cross-functional counterparts to oversee the performance of assigned vendors, including escalation of issues to governance committees and Senior Management when warranted.
- Responsible for budget planning and accountable for external spend related to clinical trial
- Work closely with Director, Clinical Operations to identify risks associated with budget management and provides mitigation strategies.
- Communicates program status, costs and issues to ensure timely decision making
- Collaborate with cross functional leaders and assigned vendors to ensure inspection readiness
- Lead Operational aspects of inspection readiness activities and act as subject matter expert during regulatory inspections
- Contribute to functional strategic initiatives and process improvement
- Advanced degree preferred (MS, Phd), Bachelor's Degree (BS) with relevant work experience also considered
- Minimum, 8 years of relevant experience in Pharmaceutical/ Biotechnology Industry, including minimum of 5 years with global project or program management
- Late Phase Oncology Experience is required (Phase III)
- Radiopharmaceutical preferred by not required
- Experience with maintaining inspection readiness or direct health authority inspections
- Working knowledge of ICH GCP and other relevant regulatory/health authority guidelines
- Demonstrates excellence in project/program management, including scenario planning, risk assessment and contingency planning
- Demonstrates leadership, flexibility, critical thinking, time management and problem-solving skills.
- Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment
- Keen Patient Focus: adopting patient perspective in all interactions and process development
- Motivated learner who is looking to advance own expertise and value
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.Benefits
- 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.