8 Director of Clinical Operations Jobs in Watertown, MA
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Abata Therapeutics is Hiring a Director of Clinical Operations Near Watertown, MA
The Role:
We are looking for an experienced Clinical Operations leader who will be responsible for the overall management of clinical operations including outsourcing, vendor management, and process development as we advance our programs to clinical trials. This individual will work closely with the management team to plan and execute the strategic direction of the function and be accountable for the execution of that strategy in partnership with our internal team and external partners. Using outstanding cross-functional skills to achieve program goals, you will develop a deep understanding of the clinical indications being pursued including knowledge of the patient needs, development precedent, regulatory guidance, and the competitive landscape in the therapeutic space.
Key Responsibilities:
Specifically, we are looking for a Clinical Operations leader with the experience, knowledge and drive to do the following:
- Lead our clinical trials to ensure deliverables (quality, compliance, timing) are met in all phases of the trial
- Pro-actively mitigate risk and partner with cross-functional stakeholders to implement mitigation strategies; monitor and manage issues to resolution throughout all phases of a trial
- Assist with the drafting of protocols, informed consent forms, study operations guidelines, site materials, manuals and other study plans
- Participate in site selection, site initiation, co-monitoring, and site close out activities
- Communicate to internal team members on deliverables and ensure timelines are met
- Develop and maintain strong, collaborative relationships with sites and key stakeholders
- Represent all aspects of Clinical Operations and provide updates as required to the senior leadership team, project teams, Board of Directors and other key internal stakeholders
Requirements and Qualifications:
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection. Therapeutic experience in genetic rare diseases and/or Hematology/oncology coupled with experience with pivotal, multi-site clinical trials is highly desirable
- Experience with global drug development and NDA/BLA filing is preferred; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs/BLAs, as well as other clinical, regulatory, and safety documents preferred
- Experience with clinical data management and pharmacovigilance is a plus
- Strong communication and presentation skills are an absolute must. This individual must have a proven track record of strong written and verbal communication skills, including the ability to relay the functional vision
- Experience leading a rapidly changing organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems
- Must have a thorough knowledge of current clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
- Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferred
- A minimum of 10 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late-stage clinical trials
Job Summary
Full Time
$242k-309k (estimate)
12/25/2022
03/24/2023
The job skills required for Director of Clinical Operations include Leadership, Clinical Operations, Clinical Research, Planning, Clinical Trial, Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Director of Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director of Clinical Operations. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director of Clinical Operations positions, which can be used as a reference in future career path planning. As a Director of Clinical Operations, it can be promoted into senior positions as a Critical Care Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director of Clinical Operations. You can explore the career advancement for a Director of Clinical Operations below and select your interested title to get hiring information.
If you are interested in becoming a Director of Clinical Operations, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Director of Clinical Operations for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Director of Clinical Operations job description and responsibilities
This position will work collaboratively with the Vice President of Operations and the Medical Directors for each service line.
04/21/2022: Memphis, TN
The director provides oversight for all clinical processes to ensure efficiency and directs staff (either directly or through other managers/supervisors).
03/11/2022: Albuquerque, NM
This will have a primary focus of ensuring quality patient care and efficient clinic operations.
04/07/2022: Green Bay, WI
Behind the scenes of most large healthcare delivery systems stands a director of clinical operations.
05/29/2022: Augusta, GA
Clinical operations directors work with the goal of boosting economical and efficient performance of their medical team while delivering high-quality patient services.
04/13/2022: Norfolk, VA
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Director of Clinical Operations jobs
A clinical operations manager oversees and directs the activities of a medical and healthcare facility.
04/16/2022: Durham, NC
Many employers prefer clinical operations manager candidates who have advanced degrees.
04/02/2022: Passaic, NJ
The Director must be disciplined about working with operations and strategy stakeholders to focus on highest value quick wins and be thoughtful about leveraging.
04/22/2022: Huntsville, AL
Additionally, all this work has to be done with rigor (no shortcuts) per country-specific Regulations and Good Clinical Practice.
03/18/2022: Springfield, OH
For a Director of Operations to excel, they should have full control over the organization’s processes.
04/16/2022: Phoenix, AZ
Step 3: View the best colleges and universities for Director of Clinical Operations.
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