Role Summary Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross-functionally to support planning, execution, and...
The Opportunity Nearshore Cyber has been retained to identify a Founding COO for a high-growth technology venture operating in stealth mode. This company is building a platform to solve the "Trust Gap" in the global cybersecurity labor market. By leveraging a new standard for verified skills, they aim to unlock liquidity between global talent and US employers. Why This Role is Different Unlike...
Company DescriptionBitron is a multinational, family-owned industrial group with a clear vision : to create products and systems that help improve the quality of people's lives and the world around them. How do we do it? Through more than 8,000 employees who work every day to shape the future of tomorrow. Bitron, thanks to over 20 production plants and more than 500 R&D employees strategically...
The Opportunity Nearshore Cyber has been retained to identify a Founding COO for a high-growth technology venture operating in stealth mode. This company is building a platform to solve the "Trust Gap" in the global cybersecurity labor market. By leveraging a new standard for verified skills, they aim to unlock liquidity between global talent and US employers. Why This Role is...
Role Summary Executive Director, Medical Writing responsible for establishing and managing the Cardiorenal Medical Writing group within BridgeBio, overseeing development and finalization of clinical and regulatory documents, and guiding internal and external Medical Writers to deliver high-quality submissions and disclosures in regulatory programs. Responsibilities Oversee the Cardiorenal Medical...
Role Summary Senior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross-functionally to support planning, execution, and...
Role Summary Executive Director, Medical Writing responsible for establishing and managing the Cardiorenal Medical Writing group within BridgeBio, overseeing development and finalization of clinical and regulatory documents, and guiding internal and external Medical Writers to deliver high-quality submissions and disclosures in regulatory programs. Responsibilities - Oversee the Cardiorenal...
Role Summary The Director of Analytical Development, reporting to the Senior Director, Analytical Chemistry, drives progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. Leads method innovation, ensures alignment with regulatory expectations, and partners cross-functionally to support process development, formulation, CMC, and quality...
Role Summary Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, responsible for developing and executing CMC regulatory strategies for Olema products in development and post-approval. Ensure strategies align with Health Authority requirements globally and provide guidance for high-quality, on-time CMC sections of regulatory submissions, plus...
Role Summary Vir Bio is seeking a Vice President, Business Development to lead global business development initiatives aligned with the organization’s strategic priorities. Reporting to the Chief Business Officer, you will maximize the value of Vir Bio’s portfolio by partnering a subset of clinical and preclinical programs and platforms, accessing complementary technologies, and leading the BD...
Role SummarySenior Director of Program Management, Oncology (NDA Lead) will lead cross-functional development and regulatory submission activities for a late-stage oncology program. This is the operational lead for the NDA submission process, ensuring alignment across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality...
A biopharmaceutical company is seeking a Senior Director of Program Management for their oncology program. This role will lead the NDA submission process, ensuring cross-functional alignment and execution. Candidates should have significant experience in biotechnology, ideally with expertise in late-stage oncology development and regulatory processes. A Bachelor's degree is required, with...
Role SummarySenior Director of Biostatistics, reporting to the VP of Biostatistics, you will lead the statistical strategy and execution of a pivotal Phase 3 clinical trial and all associated NDA activities. You will apply and share knowledge of appropriate statistical methods for clinical trial design and data analysis, and collaborate cross-functionally to support planning, execution, and...
Role Summary As a Rare Disease Specialist (RDS) at Disc Medicine, you will play a pivotal role in our inaugural commercial launch. In this highly visible, field-based role, you will translate cutting-edge science into impactful engagements with healthcare professionals who treat patients with serious hematologic conditions. You will execute a salesforce-driven lead program, strengthen existing...
Role Summary Sr. Scientist/Associate Director, Drug Substance Development and Manufacturing will support Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma. This position will be responsible for managing outsourced drug substance manufacturing activities at contract suppliers, including process validation, manufacture of raw materials and drug substance for commercial launch, and tech...
Role Summary Senior Director of Program Management, Oncology (NDA Lead) will lead cross-functional development and regulatory submission activities for a late-stage oncology program. This is the operational lead for the NDA submission process, ensuring alignment across Clinical, Regulatory, CMC Quality, and Commercial functions to meet program goals, regulatory timelines, and quality...
Role Summary Rare Disease Specialist (RDS) at Disc Medicine in a field-based, inaugural commercial launch. This role translates cutting-edge science into engagements with healthcare professionals treating serious hematologic conditions, and supports lead generation, relationship-building, and adoption of novel therapies. It combines field responsibilities with strategic cross-functional...
Role Summary Vir Bio is seeking a Vice President, Business Development to lead global business development initiatives aligned with the organization's strategic priorities. Reporting to the Chief Business Officer, you will maximize the value of Vir Bio's portfolio by partnering a subset of clinical and preclinical programs and platforms, accessing complementary technologies, and leading the BD...
Role Summary The Director of Analytical Development, reporting to the Senior Director, Analytical Chemistry, drives progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. Leads method innovation, ensures alignment with regulatory expectations, and partners cross-functionally to support process development, formulation, CMC, and quality...
Role Summary Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, responsible for developing and executing CMC regulatory strategies for Olema products in development and post-approval. Ensure strategies align with Health Authority requirements globally and provide guidance for high-quality, on-time CMC sections of regulatory submissions, plus...