- UpvoteDownvoteShare Job
- Suggest Revision
Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness (i.e. Pre-Clinical, Clinical Development, Drug Safety, Medical Affairs, Regulatory Affairs and Commercial Operations.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones.
ExpandUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of biologics.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Director, CQA coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Drug Safety/Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine and development operations.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies. Global clinical research experience and experience interacting with regulatory authorities is a plus.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
- Suggest Revision
You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs). Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
- Suggest Revision
You will report to the Sr. Director, Clinical Development and will collaborate with Clinical Pharmacology, Clinical Research, Translational Medicine, Regulatory Affairs, Biostatistics, Data Management and other functions as appropriate.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Collaborate with cross-functional teams, including clinical development, regulatory affairs, and finance, to align on trial execution plans and milestones. Ensure compliance with regulatory requirements, GCP guidelines, and company SOPs in all aspects of clinical business operations.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Utilize strategic project management skills to provide support activities across Clinical Development and across functions, including Biometrics, Data Management, Clinical Operations, Medical Affairs, Regulatory, and Safety & Pharmacovigilance.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
- Suggest Revision
Reports to the VP of Medical & Science for the U.S. East Coast Hub Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory, Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science and Rare Diseases and Advanced Therapies.
Full-timeExpandApply NowActive JobUpdated 15 days ago
regulatory affairs jobs Title: director clinical in Brookline, MA
FEATURED BLOG POSTS
How to Get a Job in a New City - Best Tips to Follow
When your dream job posts, will you be ready? What if that dream job was in a faraway city or a different continent…would you move for it? Most of us have dreamed about what it would be like to accept a job in a new place at one time or another. But when it comes to actually making a move, it’s usually the logistical details that give us pause. The key to job searching in a different location is to have a plan.
What is a Policy of Non-Retaliation & How to Create One
Your company probably has many policies in place – anti-discrimination policies, equal opportunity policies, ethics policies, and so on. However, it is important to re-evaluate whether you have a policy that covers every situation. Say for instance one of your employees submit a complaint in good faith to their supervisor. To their surprise, they are met with retaliation, such as demotion, defamation, or even termination.
When to Tell Your Boss You're Job Searching
The Bureau of Labor Statistics has found that individuals, on average, have 12.4 jobs throughout their working life. So regardless of where you are on the career ladder, it’s inevitable that at some point, you’ll begin looking for another job. That said, you might be wondering,
What Questions Can You Not Ask in an Interview?
It can be stressful to interview candidates to fill an open role at your company. Maybe your boss is on you to hire someone who’s absolutely perfect as soon as possible. Maybe you don’t have a ton of experience yet in conducting interviews. Whatever the case, there’s a lot to take under consideration when you’re the one in charge of interviewing. For instance, “What questions can you not ask in an interview?” may very well be running through your mind given its legal ramifications. Knowing exactly which interview questions are off-limits (and which are fine to ask) will boost your confidence as you continue to search for the ideal new hire.
How to Prepare to Be Fired - What You Need to Do
If you’re reading this, let me be the first to tell you how sorry I am. Getting fired feels crappy, disheartening, hurtful, and all the other bad, sad words. But here’s what I want you to do. First, let yourself fumble for a minute. Then, pick your head up — sometimes getting fired is a blessing in disguise. If you think termination is around the corner, we’ll teach you how to prepare to be fired and what to do next so you land somewhere even better.
How to Practice Fair Chance Hiring for People With Criminal Records
Usually when you think of your dream hire, you think of someone who is respectful, trustworthy, reliable, and has sound judgment, right? As you envision your ideal candidate with these qualities, the last person you think of is someone with a criminal record.
6 Common Mistakes to Avoid When Employer Branding
Currently, job searchers are putting extra effort into researching employers. The information they find plays a major role in whether they will pursue an opportunity with you or look for jobs elsewhere. That is why it is now more important than ever to be proactive and intentional when showcasing your workforce and workplace culture. Having a well crafted employer branding strategy can help you strategize and influence your potential candidates so they see your business in the best light. But in order to do that, you should be aware of some of the most common mistakes that employers make.