- Oversee the company's Clinical Development activities required to design and successfully and implement of clinical programs for regulatory approval.
- Build and support a team of professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications.
- 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.
- Provide medical and drug development expertise in the design and implementation of clinical development strategies and global clinical development plans.
- Responsible for collaborating and driving implementation of the clinical program through cross-functional teams; completing studies on time and within budget.
- Make scientific presentations at advisory boards.
- Support in-licensing and out-licensing activities and partner relationships.
- Support product lifecycle management for new indications as requested.
- Provide clinical input to regulatory, safety, and medical affairs.
- 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.
- Monitor and keep current on industry best practices, pharmacovigilance and changes in global safety regulations and guidelines.
- 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.
- Responsible for keeping the management team informed of safety issues and may work with clinical programs as a medical safety advisor.
- Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure global regulatory compliance.
- 10+ years of proven experience in clinical development, including a minimum of 7 years in a supervisory role managing (internal/external) clinical development staff, preferably at a Head of or VP level.
- MD required in a relevant scientific discipline with minimum 8 years oncology clinical development experience in bio/pharma industry, accredited residency in oncology and certification a plus.
- Ph.D., or significant research experience in immuno-oncology, immunology, molecular biology preferred.
- Industry experience within pharmaceutical and/or biologics and prior experience in FDA negotiations relating to regulatory submissions, experience in radiopharmaceuticals is strongly preferred.
- Comprehensive understanding of applicable clinical research regulations with a thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
- Extensive experience and superior proficiency in clinical development and clinical trial design.
- Fluent in Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines
- Superior proficiency in planning and project organization skills, including risk assessment and contingency planning.
- Excellent verbal and written communication and presentation skills
- Demonstrated scientific acumen, demonstrated analytical abilities, sound clinical judgment, scientific credibility, and strong integrity consistent with the company's values.
- Strong leadership experience managing direct reports, talent acquisition, team development and influencing in a matrix environment.
- Decisiveness and the ability to perform as a respected team member and leader.
- Ability to work independently to achieve objectives and lead more than one project simultaneously.
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form
- Comfortable working is a small start-up resource constrained environment.
- Ability to travel as required (up to 25%).
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Vice President Clinical Development - California, United States - Alpha-9 Oncology
4 weeks ago
Description
About us
Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceuticals for solid and hematologic malignancies. Alpha-9 has a portfolio of molecules entering clinical trials and a robust pipeline of additional targets for future development. With a strong cash position, raised from leading healthcare investors, Alpha-9 is poised to dramatically expand its team and accelerate its pipeline.
Radiopharmaceuticals, which enable internal delivery of radiation directly to tumor sites, are emerging as an exciting new class of cancer drugs. The field has evolved dramatically in the last few years, attributable to scientific advances and recent product launches. Radiopharmaceuticals are unique in that the same molecule can be used for imaging or therapeutic purposes, allowing doctors to visualize the molecule in patients prior to administration of therapy. The drug development cycle is also much shorter and capital efficient than traditional modalities.
Position Summary
The Vice President of Clinical Development will provide strategic direction and technical leadership in the development and execution of clinical development plans for all drug candidates and will be instrumental in building the company's clinical development organization. The ideal candidate will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions and proactive engagement in interactions with thought leaders, health authorities, regulatory bodies and experience working with CROs. In this role, the ideal candidate's guidance and learning throughout the planning and implementation phases will ensure clinical development timelines are met across the organization. The Vice President of Clinical Development will report to the Chief Medical Officer (CMO).
Some specific duties and tasks include, but are not limited to, the following:
Qualifications
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