Boston, Massachusetts, United States · Hybrid
$165k–$180k/yr
Job Description: Company Overview Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company ha…
Skills: Regulatory CMC, Biologics, Cell and Gene Therapy, FDA Regulations, EMA Regulations
Brewster, Massachusetts, United States · On-site
Fetal Surgery is looking for an accomplished and experienced fetal surgery researcher to support the research enterprise of incoming Chief of Fetal Surgery's research program. JOB RESPONSIBILITIES Conduct Research/Lab Ad…
Skills: Scientific Research, Lab Administration, Grant Writing, Financial Management, Personnel Supervision
Milford, Massachusetts, United States · Hybrid
$115k–$147k/yr
At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives by improving access t…
Skills: Evidence-Based Treatment, Trauma-Informed Care, Clinical Psychology, Telehealth, Case Management
Danvers, Massachusetts, United States · On-site
Gynecologist – Midlife Women’s Health & Menopause MFM Health | North Shore, Massachusetts Opportunity Overview MFM Health is seeking a board-certified or board-eligible Gynecologist to join a well-established, physician-…
Skills: Gynecology, Menopause Management, Perimenopause Care, Uterine Health, Endometriosis Treatment
Boston, Massachusetts, United States · Hybrid
$287k–$452k/yr
Job Description Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for planning and managing an important …
Skills: Academic Research, Clinical Studies, Clinical Trial Development, Dermatology, Drug Development
Danvers, Massachusetts, United States · On-site
Gynecologist – Midlife Women’s Health & Menopause MFM Health | North Shore, Massachusetts Opportunity Overview MFM Health is seeking a board-certified or board-eligible Gynecologist to join a well-established, physician-…
Skills: Gynecology, Menopause Management, Perimenopause Care, Uterine Health, Endometriosis Treatment
Boston, Massachusetts, United States · Hybrid
$311k–$489k/yr
Job Description Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduc…
Skills: Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trial Planning
Marlborough, Massachusetts, United States · Hybrid
$65k–$75k/yr
Ready for a summer schedule that works for you? ☀️ Summer Fun Fridays at Northeast Family Services! We close at 12:30pm every Friday from Memorial Day through Labor Day — giving our team more time to relax, recharg…
Skills: Behavioral Assessments, Treatment Planning, Family Consultation, Supervision of Behavior Technicians, Skill Acquisition
Springfield, Massachusetts, United States · On-site
$3k–$4k/yr
Job DetailsJob Location: Springfield, MA 01119Position Type: AdjunctSalary Range: $3,100.00 - $3,700.00 CommissionThe Department of Physical & Biological Sciences at Western New England University seeks applications for …
Skills: Biology Teaching, Laboratory Instruction, General Biology, Anatomy, Physiology
Danvers, Massachusetts, United States · On-site
Gynecologist – Midlife Women’s Health & Menopause MFM Health | North Shore, Massachusetts Opportunity Overview MFM Health is seeking a board-certified or board-eligible Gynecologist to join a well-established, physician-…
Skills: Gynecology, Menopause Management, Perimenopause Care, Hormonal Therapy, Uterine Health
Weston, Massachusetts, United States · On-site
$2k–$4k/yr
Job DetailsJob Location: Regis College Campus - Weston, MA 02493Position Type: AdjunctSummary The Department of Science, Technology, Engineering and Mathematics (STEM) at Regis College invites applications for an Adjunct…
Skills: Chemistry Teaching, Laboratory Instruction, Curriculum Alignment, Academic Assessment, Student Engagement
Burlington, Massachusetts, United States · On-site
$75k–$85k/yr
Overview This role is responsible for reviewing and assessing the medical suitability of human cardiovascular tissue donors for transplant. The position ensures compliance with FDA regulations, AATB standards, Good Tissu…
Skills: Quality Assurance, Medical Record Review, FDA Regulations, AATB Standards, Good Tissue Practices
Milford, Massachusetts, United States · On-site
Director of Engineering ISO and ITAR Compliant Job Description Job Information • Job Title: Director of Engineering • Company: PEI • Department: Engineering • Reports To: General Manager • Locati…
Skills: Photochemical Etching, GD&T, ISO 9001, AS9100, ITAR Compliance
Hyannis, Massachusetts, United States · On-site
Responds to psychiatric emergencies utilizing training in management of aggressive behaviors. Demonstrates skills and takes initiative in preventing situations from escalating by recognizing potential at-risk situations …
Skills: Psychiatric Emergency Management, De-escalation, Psychoeducation, Patient Advocacy, Case Management
Hyannis, Massachusetts, United States · On-site
Responds to psychiatric emergencies utilizing training in management of aggressive behaviors. Demonstrates skills and takes initiative in preventing situations from escalating by recognizing potential at-risk situations …
Skills: Crisis Intervention, Psychopharmacology, Addictive Disease Assessment, Case Management, Advanced Diagnostic Skills
Hyannis, Massachusetts, United States · On-site
Responds to psychiatric emergencies utilizing training in management of aggressive behaviors. Demonstrates skills and takes initiative in preventing situations from escalating by recognizing potential at-risk situations …
Skills: Psychiatric Emergency Management, De-escalation, Psychopharmacology, Addictive Disease Assessment, Crisis Intervention
Hyannis, Massachusetts, United States · On-site
Responds to psychiatric emergencies utilizing training in management of aggressive behaviors. Demonstrates skills and takes initiative in preventing situations from escalating by recognizing potential at-risk situations …
Skills: Psychiatric Emergency Management, De-escalation, Psychopharmacology, Addictive Disease Assessment, Crisis Intervention
Boston, Massachusetts, United States · On-site
$131k–$196k/yr
The opportunity: Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start-up through close-out. Reporting to the Director of Clinical Data Sciences, you'll independe…
Skills: Clinical Data Management, Vendor Oversight, CRF Design, Data Reconciliation, Medical Coding
Waltham, Massachusetts, United States · Hybrid
$185k–$206k/yr
The Associate Director (AD), Medical Information & Review will participate in the medical review and approval of external communication materials. The AD will be responsible for providing and supporting the provision of …
Skills: Medical Information, Medical Review, Promotional Review, Medical Affairs, Scientific Literature Monitoring
Boston, Massachusetts, United States · On-site
The School of Pharmacy-Boston seeks an adjunct faculty member to deliver high quality learning experiences and education for students in the Doctor of Pharmacy (PharmD) program. The selected candidate will have responsib…
Skills: Didactic Instruction, Curriculum Development, Student Advising, Learning Management Systems, Communication Skills
Boston, Massachusetts, United States • Hybrid
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Act as the Regulatory CMC Lead for assigned programs, providing strategic guidance and preparing high-quality global applications such as INDs and CTAs. Lead Health Authority meeting strategies and manage relationships with internal and external stakeholders to advance gene-based medicines.
Requires a Bachelor's degree in a scientific field and 10-12+ years of relevant Regulatory CMC experience in biologics or cell and gene therapies. Must possess deep knowledge of FDA, EMA, and ICH regulations and experience with eCTD submission requirements.
Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
This position is a key leadership role for the development of the Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Associate Director, Regulatory Affairs CMC: Base pay range of $165,000 to $180,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
Since its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Offices: 105 West First Street, Boston, MA 02127, US · Baarerstrasse 14-16, Zug, CH CH-6300, CH · 90 Fetter Lane, London, England EC4A 1JP, GB · 455 Mission Bay Blvd S, San Francisco, California 94158, US
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