Source Job

• Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms.
• Oversee technology transfer from development to clinical and commercial manufacturing.
• Manage CDMOs, including selection, oversight, and performance management.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania.

• 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.

• Plan, direct, and oversee drug substance process development from pre-clinical to commercial launch.
• Optimize processes using Quality by Design (QbD) principles.
• Mentor and develop direct reports and team members.

Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly and fairly. They identify top-fitting candidates and share the shortlist with the hiring company.

• Independently lead multiple product development programs.
• Serve as the primary technical owner for assigned projects.
• Drive continuous product improvement initiatives.

The VMS Co-Op includes fast-growing companies in the Vitamins, Minerals, and Supplements (VMS) space, such as OLLY and SmartyPants. This company values collaboration and offers various benefits including parental leave and wellness stipends.

• Provide strategic and technical leadership to support and lead statistical activities for clinical trials across multiple studies.
• Lead the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials.
• Serve as a key statistical representative in cross-functional team discussions and governance meetings

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. ClinChoice considers their employees the most valuable company asset and focuses on close management and training to develop highly-qualified personnel.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.

Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.

• Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
• Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
• Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.

American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.

• Assume leadership and functional representation for projects ensuring effective coordination and management of regulatory deliverables.
• Perform quality control of regulatory intelligence screening and ensure maintenance of the regulatory intelligence database.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk.

PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They have achieved global organic growth year after year, with staff based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

• Serve as QA owner for clinical-stage combination product complaints.
• Ensure timely assessment of complaints for potential impact to patient safety.
• Partner with Regulatory Affairs and Pharmacovigilance to support complaint-related regulatory submissions.

Akero Therapeutics, a Novo Nordisk company, is dedicated to discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They foster a collaborative environment where diverse skill sets and backgrounds are valued, encouraging employees to bring their best thinking to work.

• Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
• Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
• Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

• Prepare, compile, and submit regulatory documents to IRBs/ECs
• Support migration from Complion to Florence eRegulatory
• Maintain CVs, licenses, and GCP documentation

UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.

• 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.