- Madrigalpharma (Conshohocken, PA)
- …include overseeing biostatisticians, contributing to clinical submissions, and engaging with external scientific leaders. The role requires 3 days onsite per week, ... A biopharmaceutical firm in Conshohocken is seeking an Executive Director of Biostatistics to lead biostatistical activities in clinical development. The ideal candidate will have a Ph.D. in Statistics or Biostatistics and over 10 years of experience in Pharma… more
- Chapter 13 Trustee Middle District of Alabama (Jacksonville, FL)
- …on all legal components of the Company's robust development pipeline, from the NDA stage to accepting first patients. The Company's development pipeline continues to ... projects. The responsibility includes negotiating and drafting agreements from the NDA stage to closing, and advising on business, corporate governance, regulatory,… more
- Xeris Pharmaceuticals (Chicago, IL)
- …Write development reports for internal reference, relevant sections of IND, NDA and other regulatory documentation. Adhere to department budgets Qualifications A ... as well as in a team. Prior knowledge of successful regulatory submissions (IND/ NDA /BLA) and commercial method support is a plus. Ability to draft routine reports… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Investigational New Drug (IND), IND amendment, original New Drug Application ( NDA ), supplemental NDAs, and routine submissions (eg, Development Safety Update Reports ... regulatory documents, including meeting requests, Module 1 documents for original IND/ NDA , etc. May oversees and guides labeling, packaging and associated… more
- Neurocrine Biosciences (San Diego, CA)
- …components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA -stage projects* Proficient with the use of PK and PK/PD Modeling software ... tools including NONMEM, R and WinNonlin* Significant expertise in preparing NDA /MAA summaries of population modeling analyses would be highly beneficial* Strong… more
- NCBiotech (Raleigh, NC)
- …designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA , briefing books, Investigator Brochures, etc.). Additionally, they will frequently ... the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA , briefing books, Investigator Brochures, etc.). Represent Translational Medicine on… more
- Cedent Consulting Inc. (San Francisco, CA)
- …method development, building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred. Experience ... aspects required to building control strategy, assembling data and authoring an NDA for a small molecule commercial product is highly preferred. Working… more
- STERLING GROUP LP (Houston, TX)
- …structures remain aligned with evolving regulations and investor expectations. Manage firm's NDA counsel, including maintenance of NDA negotiation playbook and ... direct resolution of contentious issues. Manage firm's insurance program, including relating to professional liability (D&O, fiduciary, EPL, crime), cyber, general liability and property and casualty. Offer advice to the firms portfolio companies on the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …processes and technology transfers Author sections of regulatory documents (eg, IND, NDA , IMPD, BLA, PAS) in support of global regulatory submissions Knowledge, ... processes and technology transfers Author sections of regulatory documents (eg, IND, NDA , IMPD, BLA, PAS) in support of global regulatory submissions Knowledge,… more
- Exelixis, Inc. (Alameda, CA)
- …New Drug (IND), Clinical Trial Application (CTA), New Drug Application ( NDA ), and Biologics Licensing Application (BLA) submissions and preparing amendments in ... US INDs.* Assist Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission… more
- AskBio Asklepios BioPharmaceutical, Inc. (Durham, NC)
- …designs, execution, and reporting to support regulatory submissions (IND, CTA, NDA , briefing books, Investigator Brochures, etc.). Additionally, they will frequently ... the preparation of Toxicology sections of regulatory documents (IND, CTA, NDA , briefing books, Investigator Brochures, etc.)* Represent Translational Medicine on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross‑functional partners to ... applicable, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team… more
- Pierre Fabre Pharmaceuticals Inc. (Secaucus, NJ)
- …to planning Agency interactions, and lead interactions with FDA (INDs, NDA /MAAs, DSURs, PIND/EOP2 meetings, etc.) in collaboration with the Corporate Regulatory ... of US regulations and regulatory requirements, and operational knowledge of IND/ NDA /BLA submissions* Strong track record of building an excellent relationship with… more
- Revolution Medicines (Redwood City, CA)
- …quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA , MAA and amendments to Health Authorities (HAs), and preparation of ... CMC regulatory affairs. Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA , MAA, etc.) (US, EU, APAC, LATAM). Solid knowledge of US and… more
- Takeda (Boston, MA)
- …supporting an initial IND/IMPD preparation, or supporting an initial NDA /BLA. Strong practical experience with global HA requirements, beyond EU/US. ... Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post‑market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post‑market support… more
- Gruve Inc. (Dallas, TX)
- …not solicit such information, in accordance with the Non-Disclosure Agreement * Select NDA I consent to the use of AI-powered note-taking tools during the interview ... process and acknowledge that the interview may be recorded and stored for evaluation purposes. * Select #J-18808-Ljbffr more
- Echo (San Francisco, CA)
- …All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process. #J-18808-Ljbffr ... Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life. Team Culture Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment… more
- Montgomery College (Baltimore, MD)
- …, data sharing agreements , easements, intergovernmental agreements, leases, NDA "s, performance agreements, purchase agreements , maintenance agreements, real estate ... agreements, service agreements and software licenses.* Provides legal advice and counsel throughout procurement process, including RFP's, bid protests, and contract formation.* Represents in the College in commercial litigation or mediation and/or assists or… more
- Cerebras (San Francisco, CA)
- …Structuring Deal Processes: Encode and standardize processes for CIM evaluation, NDA /legal document understanding, and deal sourcing workflows for AI use. Practice ... Leadership: Build and lead a team of financial experts to continuously refine and expand the finance knowledge base used for model training. Quality Assurance: Establish metrics and review loops to evaluate model outputs and ensure fidelity to financial logic… more
- plasma.to (New York, NY)
- …partnerships, vendor & service agreements, grant or collaboration agreements, confidentiality/ NDA arrangements, and more. Identify, assess, and mitigate legal and ... regulatory risk tied to new products, partnerships, operations, and strategic initiatives, acting as a key risk-management partner for the business. Advise on compliance approaches with our GC and CCO : from licensing and money-transmission issues to… more
