- Oversee the conduct of nonclinical studies to support Ardelyx programs, including non-GLP and GLP toxicology, pharmacology, and DMPK studies
- Identify/qualify new or existing CROs
- Serve as the Nonclinical representative during GLP audits
- Author and review SOPs and policies related to the Nonclinical function
- Oversee study logistics, including managing contracts with vendors, tracking invoices and payments, and procuring/shipping study materials
- Conduct study monitoring visits
- Review and evaluate study protocols, data, and reports
- Author and review regulatory documents including IND, NDA/BLA, IB, and DSUR
- Prepare and present study updates to internal project teams and senior management
- PhD or advanced degree in toxicology, pharmacology, biology, or related scientific discipline with 7+ years of relevant work experience in the pharmaceutical industry or equivalent experience
- In-depth knowledge and technical oversight of nonclinical toxicology, pharmacology, and DMPK studies
- Experience conducting or overseeing nonclinical studies with small and large molecules is preferred
- Extensive knowledge of GLP principles and FDA/ICH guidelines
- Ability to analyze/interpret complex data and troubleshoot
- Highly organized with excellent written and oral communication skills
- Experience as a supervisor is a plus
- Ability to work effectively with cross-functional R&D colleagues
- Work in company
Director, Quality Assurance – Clinical and Nonclinical Development
Only for registered members
· Company Overview: · Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editi ...
Watertown, MA $207,000 - $253,000 (USD) per year3 days ago
- Work in company
Director, Quality Assurance – Clinical and Nonclinical Development
Only for registered members
Prime Medicine is seeking a Quality Assurance (QA) Director to serve as the company's primary quality assurance expert across both clinical and nonclinical programs. · 10+ years in GCP/Clinical Quality Assurance. · Demonstrated success as a primary or sole QA lead supporting earl ...
Watertown, MA1 month ago
-
Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. · ...
Waltham $190,000 - $212,000 (USD)3 weeks ago
-
The Associate Director in Nonclinical Safety Evaluation will lead the design and implementation of nonclinical safety assessment strategies to support Alkermes' drug candidates. The role requires a strong understanding of toxicology and regulatory requirements to progress candida ...
Waltham, MA, United States2 weeks ago
-
The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and ...
Waltham23 hours ago
-
Associate Director in Nonclinical Safety Evaluation designing and implementing nonclinical safety assessment strategies. · * Design and implement nonclinical safety assessment strategies* Communicate strategies and findings internally and to regulatory authorities globally · * Al ...
Waltham Full time1 month ago
-
We are seeking a highly motivated and experienced quantitative clinical pharmacologist to join our Clinical Pharmacology department. · The Sr. Manager will serve as the Clinical Pharmacology Lead, providing subject matter expertise and strategic guidance. · Hands-on modeling expe ...
Waltham1 month ago
-
The Associate Director in the Nonclinical Safety Evaluation organization is responsible for designing and implementing nonclinical safety assessment strategies to support the nomination and development of Alkermes' drug candidates. · Design and implement nonclinical safety assess ...
Waltham, MA1 month ago
-
The client has an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join their team supporting CNS therapeutic area as a key member of their department. · The position will have a core scientific responsibility of selecting optima ...
Waltham, MA1 month ago
-
About Us · We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s comp ...
Waltham4 days ago
-
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...
Waltham $127,000 - $155,000 (USD) Full time1 week ago
-
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. · The Director, Regulatory Operations, will be responsible for day-to-day submission management activities of ...
Waltham $190,400 - $238,000 (USD) Full time2 weeks ago
-
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring developing and commercializing products across the globe Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual orga ...
Waltham $190,400 - $238,000 (USD)2 weeks ago
- Work in company
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
Only for registered members
+Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. · ++Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field, Hematology/CVR/Transp ...
Waltham3 weeks ago
- Work in company
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
Only for registered members
Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. · Analyze the factors mentioned in this job description to determine the estimated salary range for this position. · ...
Waltham1 month ago
- Work in company
Senior Manager, Regulatory Project Management and Operations
Only for registered members
The Senior Manager of Regulatory Project Management and Operations leads planning coordination delivery high-quality regulatory submissions global health authorities. · ...
Waltham $130,000 - $200,000 (USD)1 month ago
- Work in company
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
CSL Behring
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team co ...
Waltham Full time1 day ago
-
· At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kai ...
Waltham, Massachusetts5 days ago
-
We are looking for a highly motivated and organized professional who is passionate about making a positive impact on our business, our industry, and, ultimately, · our patients.Support the Search and Evaluation function to proactively · & systemically identify external opportunit ...
Waltham $139,000 - $169,000 (USD) Full time3 weeks ago
-
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. · Ardelyx has two commercial products approved in the United States IBSREL ...
Waltham $139,000 - $169,000 (USD)3 weeks ago
-
We seek a dynamic Director/Sr Director Clinical Pharmacology to lead scientific strategic direction of clinical pharmacology across development pipeline. · This role shapes early late stage clinical programs drives dose selection study design PK/PD analysis quantitative modeling. ...
Waltham, MA1 month ago
Associate Director, Nonclinical Development - Waltham - Ardelyx
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: We are seeking an Associate Director of Nonclinical Development to join our experienced R&D team supporting drug development programs. The Associate Director will design and implement nonclinical strategies to evaluate and advance Ardelyx's drug candidates through different stages of development. This position involves designing and managing GLP safety studies at contract research organizations (CROs) for early and late-stage programs, analyzing and interpreting safety data, and collaborating with cross-functional teams. Responsibilities:-
Director, Quality Assurance – Clinical and Nonclinical Development
Only for registered members Watertown, MA
-
Director, Quality Assurance – Clinical and Nonclinical Development
Only for registered members Watertown, MA
-
Senior Scientist, Toxicology
Only for registered members Waltham
-
Associate Director, Non Clinical Safety Evaluation
Only for registered members Waltham, MA, United States
-
Associate Director, Non Clinical Safety Evaluation
Alkermes, Inc.- Waltham
-
Associate Director, Non Clinical Safety Evaluation
Full time Only for registered members Waltham
-
Clinical Pharmacologist
Only for registered members Waltham
-
Associate Director, Non Clinical Safety Evaluation
Only for registered members Waltham, MA
-
Sr. Manager, Clinical Pharmacology
Only for registered members Waltham, MA
-
Executive Director
Only for registered members Waltham
-
Manager, Nonclinical Operations
Full time Only for registered members Waltham
-
Director, Regulatory Operations
Full time Only for registered members Waltham
-
Director, Regulatory Operations
Only for registered members Waltham
-
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
Only for registered members Waltham
-
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
Only for registered members Waltham
-
Senior Manager, Regulatory Project Management and Operations
Only for registered members Waltham
-
Associate Director Clinical Assay Strategy, Hematology and Cardiovascular
Full time CSL Behring- Waltham
-
Manager, Nonclinical Operations
Only for registered members Waltham, Massachusetts
-
Senior Manager, Corporate Development and Strategy
Full time Only for registered members Waltham
-
Senior Manager, Corporate Development and Strategy
Only for registered members Waltham
-
Director/Sr. Director, Clinical Pharmacology
Only for registered members Waltham, MA