Project Manager, Cmc

2 weeks ago

Toronto, Canada POINT Biopharma Full time

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 CANADA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Reporting to the Director, CMC, the Project Manager will support the CMC team through planning, coordination, documentation, and maintenance of timelines for multiple development and manufacturing programs.

Objectives
- Build and manage integrated program timelines; awareness and anticipation of interdependencies and resource needs; establish and track program goals
- Facilitate and manage productive external partner and cross function research program team meetings (prepare agenda, minutes), ensure progress towards program goals, hold team members accountable for action items, maintain a sense of urgency and focus to drive critical decision making
- Lead the identification and management of critical path activities. Proactively identify risk and document contingency or mitigation plans
- Monitor issues through resolution and ensure that all key stakeholders are informed of outcomes and program implications
- Maintain current and accurate program timelines and metrics, if requested, by obtaining key stakeholder and management input and approval

Accountabilities
- Analyze competing priorities across multiple projects
- Analyze the actual performance against the plan and make adjustments consistent with plan objectives
- Prepare reports, summaries, presentations that provide status updates for ongoing projects and programs
- Ensure that all team members understand their roles and accept their responsibilities
- Establish and publish clear priorities among project activities and across competing program deliverables
- Manage project plans across multiple programs with aggressive and challenging timelines

**Requirements**:

- BS/BA in science related field
- PMP or equivalent certification
- Functional knowledge of GMPs, GLPs, eCTD Module 3 and other relevant regulatory/health authority guidelines
- 5+ years of relevant working experience in the pharmaceutical/biotechnology industry in discovery, preclinical or clinical manufacturing operations, oncology preferred
- Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
- Ability to negotiate with professionalism and influence

Competencies
- Expert ability with project and program management software; advanced ability with Asana preferred
- Experience with SharePoint, Excel, PowerPoint and Word
- Organized and systemic approach to prioritization
- Ability to work independently, be and effective communication and an engaged team member in a dynamic, fast-paced environment
- Exemplifies collaboration, teamwork, and professionalism
- Motivated to learn or advance own expertise and value
- Able to influence and drive results

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 resume.

**Benefits**
- Healthcare (medical, dental, vision)
- Disability
- Life insurance
- RRSP matching plan
- $500 fitness reimbursement
- $100 cell phone reimbursement per month

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, p

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