About this role
- Our client who is a clinical-stage oncology company is seeking an Associate Director of Clinical Operations as they grow the team in Boston Massachusetts.
- The Associate Director of Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical programs.
- The Associate Director may lead or sponsor Clinical Operations organizational initiatives;
- The core duties and responsibilities of the Associate Director include, but are not limited to;
- Provide operational and implementation expertise to the company project teams to enable timely progression of clinical development programs;
- Clinical trial operational lead for clinical development program ensuring successful planning, implementation and conduct of all assigned clinical trials;
- Oversight and management of CRO to ensure timelines of clinical development plans are met;
- Work with the project team to identify and evaluate issues in the program, interpret data on complex issues and suggest and implement solutions;
- Participate in design and development of clinical trial protocols;
- Provide oversight for development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials;
- Contribute and assist with the development of the clinical components of regulatory submissions;
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites;
- Oversee and manage clinical development program budget;
- Work on complex program issues in which analysis of situations or data require an in-depth evaluation of various factors;
- Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, tracking metrics, producing and presenting summary reports;
- Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations;
- Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines;
- Contribute to and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards;
- Lead and mentor others in Clinical Operations.
- BA/BS in a scientific field of study with 10+ years of relevant experience working in in the pharmaceutical/ biotech industry;
- Oncology Experience Required;
- In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge;
- Experience in developing Clinical Operations SOPs and metrics;
- Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment;
- Strong collaboration and team-working, communication and organizational skills required;
- Strong problem solving and analytical skills necessary;
- Ability to prioritize and manage time demand, incomplete information, and unexpected events;
- Willing to travel domestically and internationally.
What we offer
- Why apply through Brunel?
Finding the next step in your career can be a fulltime job in itself;
- We manage
the process for you: from submitting your resume to coordinating interviews to
extending offers and assisting with on-boarding;
- We’ll get you going while you
get on with the job.
Join the Brunel Family
- Brunel has a reputation for working with some of the best in the business;
- That’s what we continually strive for;
- Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services;
- Join us today.
We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.
After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.
During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.
After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.
Submission of candidates resume for client’s approval and screening.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto