Director of Drug Product Development
Roivant SciencesSalary not specified
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Medical Degree (MD) required; specialization in autoimmune, neurology or neuromuscular
- Minimum 15 years of experience in pharmaceutical/biotech drug development
Responsibilities
- Lead the overall development strategy for assigned drug programs, ensuring clear objectives, timelines, and deliverables are established and met
- Provide scientific leadership across early-stage development through post-marketing activities
- Represent the company in external forums, including scientific conferences and regulatory discussions
- Oversee clinical trial design, execution, and data interpretation
- Lead site selection, patient enrollment, and medical monitoring
- Ensure safety oversight and pharmacovigilance across all clinical programs
- Guide regulatory submission planning and execution, ensuring compliance with global requirements and facilitating interactions with health authorities; partner with regulatory affairs on submissions including INDs, NDAs, BLAs, and CTAs
- Build and mentor a high-performing medical team, fostering a culture of innovation and collaboration
- Collaborate with clinical, regulatory, medical, commercial, manufacturing, and other functional teams to integrate activities and resolve challenges throughout the development lifecycle
- Develop and maintain comprehensive program plans, including risk assessments, mitigation strategies, and contingency plans to address potential obstacles
- Serve as the primary contact for internal and external stakeholders, including senior management, global project teams, external partners, and regulatory authorities
- Provide regular updates to leadership and teams, preparing high-quality presentations, reports, and documentation to support decision-making
- Oversee program budgets, resource allocation, and financial forecasting to ensure efficient use of assets and adherence to organizational priorities
- Track program progress against milestones, proactively identify issues, and implement corrective actions to maintain momentum and achieve objectives
- Provide oversight of Pharmacology, Toxicology, Medical Writing, and Biometrics
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What are the key responsibilities of the VP, Global Drug Development Program Lead?
The role involves leading the overall development strategy for drug programs, overseeing clinical trial design and execution, ensuring regulatory compliance, representing the company externally, and building a high-performing medical team.
What teams or functions does this role oversee?
This role has oversight of Pharmacology, Toxicology, Medical Writing, and Biometrics.
What is the compensation or salary for this position?
This information is not specified in the job description.
Is this role remote or does it require office presence?
This information is not specified in the job description.
What does Vor Bio's company culture emphasize?
Vor Bio emphasizes a culture of belonging where every voice is heard, shared mission unites teams across functions and geographies, innovation, impact on patients, and career growth opportunities.
Vor Bio
Develops targeted therapies for blood cancers
About Vor Bio
Vor Biopharma focuses on developing treatments for blood cancers, particularly Acute Myeloid Leukemia (AML). Their approach is designed to protect healthy cells while specifically targeting and eliminating cancerous cells. This method aims to improve the effectiveness of blood cancer treatments. Vor Biopharma serves patients with blood cancers, their caregivers, and medical professionals in hospitals and oncology centers. What sets Vor Biopharma apart from competitors is their strong emphasis on research and development, investing significantly in scientific research to create a proprietary platform and pipeline of therapies. They generate revenue through partnerships with other pharmaceutical companies and licensing agreements, with the goal of commercializing their therapies after obtaining regulatory approval. The company's mission is to transform the treatment landscape for blood cancers by providing innovative therapies that prioritize patient safety and efficacy.
Cambridge, MassachusettsHeadquarters
2015Year Founded
$147.9MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
