Director of Clinical Success
Abridge$260,000 - $300,000/year
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Provide strategic leadership for clinical development strategy, planning, and tactical implementation for all clinical development functions
- Serve as the Clinical Development Leader (CDL) for one of Septerna’s clinical stage programs
- Ability to bridge clinical, scientific, and business needs with aptitude to translate and align business and scientific goals and objectives
- Dynamic leader with outstanding strategic, communication, and collaboration skills
Responsibilities
- Enterprise leader of program strategy, collaborating in a matrixed working environment with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs
- Work with key internal and external stakeholders to lead the design and implementation of robust CDPs to achieve the desired target product profile
- Guide the development team(s) with aggressive, creative, but realistic approaches to drug development
- Direct and design fit-for-purpose clinical trials across all phases in drug development; design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents
- Contribute to IBs, regulatory documents, CSRs, and publications associated with clinical trials
- Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
- Be accountable via collaboration across functions and clinical operations for all relevant timelines and deliverables
- Collaborate with regulatory affairs to develop high-quality strategic regulatory strategies and engagement
- Participate in regulatory interactions and contribute to building relationships with KOLs
Skills
Clinical Development
GPCR Drug Discovery
Preclinical Research
Therapeutic Development
Biotechnology
Drug Discovery
Structural Biology
Small Molecule Programs
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
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