Provide medical expertise and leadership in clinical development strategies aligned with company objectives.
Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
Serve as medical monitor for clinical trials and ensure adherence to ICH GCP, patient safety, and data integrity.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K, they are committed to a culture of collaboration, excellence, and impact and empower every individual to be their true selves and grow alongside the company’s success.
Leads cross functional development of integrated program plans.
Tracks program risks by proactively identifying and resolving issues.
Ensures effective communication of program information.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade was launched based on assets licensed from Paragon Therapeutics and has multiple antibody candidates in preclinical development.
Create and maintain detailed integrated project plans.
Partner with cross-functional teams to drive alignment.
Identify and manage project risks and mitigation strategies.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Lead the development, manufacturing, assembly, and commercialization of high‑concentration biologic delivery systems.
Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks.
Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. It appears to be a growing company with a focus on innovation.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Lead strategic planning and execution of Medical Affairs initiatives aligned with corporate objectives.
Drive operational excellence through process improvement, change management, and performance tracking.
Partner with cross-functional stakeholders to ensure seamless integration of medical strategies.
Kardigan is a heart health company working to make cardiovascular disease preventable and curable. They're driven by patients and their families, deeply committed to improving lives and prioritizing patient needs, authentic, always learning, winning as a team, and enabling the impossible.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Provide senior strategic Regulatory CMC leadership across Antares’ portfolio.
Advise on CMC readiness for INDs and global CTAs, ensuring alignment with clinical development plans and corporate objectives.
Guide the integration of CMC regulatory considerations into early development, manufacturing, and supply decisions.
Antares Therapeutics is focused on bringing transformative oncology therapies to patients. They operate with cross-functional teams including Global Regulatory Affairs, Technical Operations, Quality, and Supply Chain to meet corporate objectives.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops 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, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
Perform review of executed batch records and test data and perform product disposition
Lead and support quality audits of contract service providers
Jobgether is a company that connects job seekers with employers through an AI-powered matching process. They focus on ensuring applications are reviewed quickly and fairly, and they value talent development.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Review analytical data for release, stability, and in-process testing.
Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
BridgeBio pioneers a “moneyball for biotech” approach. They pool projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation and build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines.
Lead and develop virtual program teams to drive accountability and high performance.
Serve as the principal customer liaison and build robust, trustful relationships.
Own program P&L elements, conduct scenario planning, and drive change orders.
FUJIFILM Biotechnologies is dedicated to making a real difference in people's lives by partnering with innovative biopharma companies to develop vaccines, cures, and gene therapies. They foster a culture of passion, energy, and drive, encouraging personal and professional growth.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.