Head of Business Development
PhantomSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
- MD or MD/PhD required and 10+ years of experience in Clinical Development or related pharmaceutical capacity
- Endocrinology/Board Certified Endocrinologist preferred
- Proven track record of drug development in multiple therapeutic areas
- Rare disease experience is preferred
- Excellent communicator with team building and collaboration skills
- In depth knowledge of drug development process and oversight of clinical trials; well versed in first-in-human trials as well as late phase development and product filing/ registration
- Has seen and managed significant accelerations and challenges in clinical programs
- Outstanding management skills a must, both with respect to managing the development team but also evidence of successful enterprise/matrix leadership
- Demonstrated ability to lead cross-functional teams to make significant recommendations and persuasively present synthesis of team diligence to gain alignment with senior management
- Expertise in innovative clinical trial design, scientific writing, and the successful implementation of clinical protocols
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
- Communicate to management and relevant functions any potentially significant issues to the CDP or emerging safety risks in a timely manner
- Provide strategic consultation and guidance to Research on decision that have significant clinical components and implications
- Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements
- In conjunction with the Chief Medical Officer, ensure organizational growth plans for clinical Development scales with Septerna’s current and future needs
- Mentor and develop more junior physicians and other clinical development staff to successfully advance to higher levels of responsibility
- Travel to clinical sites, conferences, and regulatory meetings as needed
Skills
Clinical Development
Drug Development
Clinical Trials
Protocol Design
Regulatory Interactions
KOL Engagement
Cross-Functional Leadership
Clinical Operations
Clinical Pharmacology
CMC
Medical Oversight
Safety Monitoring
Clinical Study Reports
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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