Clinical Development Associate - Remote

Company: POINT Biopharma
Location: San Antonio
Posted on: November 22, 2021

Job Description:

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

We are seeking a collaborative and adaptable individual to join the clinical team as a Clinical Development Associate. The Clinical Development Associate.will report to the Associate Director (AD) Clinical Science, and support deliverables for the AD, clinical development team, and other internal stakeholders.

They will become an expert in the most recent concepts and literature related to radioligand therapy in oncology, and they will work intimately with data from ongoing trials, all to support the overall development of new radioligand therapies for the treatment of cancer. As the organization is in the preclinical stage, priorities and tasks may change quickly.

Responsibilities
Provide review and management of key clinical study documents including study synopsis, protocols, ICFs, IBs, case report forms, DMC charters, patient guides, DSUR/IND annual reports, IRB/EC responses.
Support the AD, Clinical Science with deliverables and inquiries related to ongoing studies
Generate clinical landscape updates and reviews
Monitor and mine clinical trial data for trends
Assist with patient profile or clinical science reviews
Conduct research and literature reviews
Maintain a high level of expertise with clinical literature to serve as an internal subject matter expert of a given topic
Additional Responsibilities as assigned

Accountabilities
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 indications, literature updates
Participate in the review and management of clinical protocols, study manuals, ICFs, IBs, DMCs, study tools and other essential documents
Attend selected conferences (digital and in-person) and provide critical updates to AD, Clinical Science
Engage with internal stakeholders for support of ongoing clinical studies.
Participate in the planning and execution of Investigator meetings
Support the development of content and execution of Advisory Board Meetings
Support abstract and manuscript writing
Manage clinicaltrials.gov content and requirements

Requirements
Pharm D or MPH/MS; or BSc with relevant work experience
Relevant working experience in health/life sciences required (fellowships/placements permitted)
Oncology experience preferred
Professional writing experience preferred
Experience in data analysis and interpretation required
Experience in interpretation and distillation of key concepts from scientific papers/academic journal articles required

Competencies
Expert proficiency in Excel, Word, and PowerPoint (required)
Ability to quickly adapt to new tools, frameworks, and processes; and adopt these for ongoing projects
Ability to understand new scientific concepts and information and apply these in a changing environment
Excellent analytical skills, expertise with database or data visualization software is an asset
Inherent drive to cultivate collaboration, teamwork and professionalism
Organized with high attention to detail, accuracy and completeness
Patient Focus: adopting patient perspective in all interactions
Motivated to learn or advance own expertise and value
Ability to work independently and an engaged team member in a dynamic, fast-paced and lean environment

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.

Keywords: POINT Biopharma, San Antonio , Clinical Development Associate - Remote, Healthcare , San Antonio, Texas