The Senior Director of Clinical Development will provide direction and technical leadership in the development and execution of clinical development plans for drug candidates and contribute to the Clinical Development strategy.
Requirements
- Design and direct Phase 0-3 clinical trials for radioligand therapy compounds.
- Author and/or collaborate with clinical and other teams to create documents such as Study Concepts/Synopses, Protocols, ICFs, Investigator Brochures, INDs, NDAs, Briefing Documents, abstracts, manuscripts and provide medical and scientific input into the development of deliverables required for study activation, conduct, and closure (CRFs, SAP, Data Listings, CSRs, etc.)
- Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization.
- Ensure clinical trials are conducted according to good clinical practice and all applicable regulatory requirements, standard operating procedures, and other quality standards.
- Responsible for collaborating and driving implementation of the clinical program through cross-functional teams; completing studies on time and within budget.
- Contribute to and optimize an effective KOL and investigator communication strategy. Interact with investigators as warranted to obtain necessary information before, during and after the study.
- Organize and present at KOL advisory board and investigator meetings.
- Provide medical review, analysis and medical guidance during the case handling and reporting process for Adverse Event and Adverse Reaction reports received for the Company’s investigational products.
- Plan, oversee and direct risk management activities for investigational compounds.
- Respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Monitor and keep current on industry best practices, pharmacovigilance and changes in global safety regulations and guidelines.
- Train/mentor colleagues, CRO and study site staff on the therapeutic area, molecule, and clinical documents as appropriate.
- Working with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are appropriate for a matrixed environment.
- Support product lifecycle management for new indications as requested.
Benefits
- Competitive salary
- Bonus
- Equity
- 20 vacation days
- 5 sick days
- Technology allowance
- Commuter reimbursement
- Generous retirement savings plans with employer matching
- Extended health benefits
- Paid holidays, tailored to local standards in each region
