Vice President, Clinical Development
Clinical | San Carlos, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders, and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
Reporting to the Chief Medical Officer, the Vice President, Clinical Development will be the Clinical Lead for the avacopan programs in renal diseases (ANCA-Associated Vasculitis and C3 Glomerulopathy as well as for a development program in Lupus Nephritis).
Essential Duties and Responsibilities
- Oversee development of protocols and cooperate in the development of other necessary documents for clinical studies, providing expert medical input throughout
- Provide expert input at meetings and interactions with health authorities and in response to questions posed by health authorities
- 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
- Partner with internal and external experts and consultants to refine the clinical development plan and to optimize the scientific integrity of the methodology and ensure that the overall scientific and medical content of all clinical programs is sound
- Provide clinical/scientific input during the development and execution of clinical trials
- Write and/or review clinical sections of clinical/statistical reports, including data presentations and other regulatory submissions
- Interpret clinical trial data, including participating in safety assessments
- 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 and post-market assigned products
- Be accountable for all relevant timelines and deliverables
- Provide medical safety expertise and training, as required
- Keep current with professional and Pharmacovigilance regulations and knowledge
- Plan, oversee and direct risk management activities for investigational compounds and marketed products
- 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 the clinical programs as a medical safety advisor
- Monitor industry best practices and changes in global safety regulations and guidelines
- Recommends changes and upgrades to existing departmental policies, SOPs, and systems to ensure global regulatory compliance
- Nephrologist MD with a minimum of ten years of industry experience in clinical development in the biopharmaceutical/biotech industry including a minimum of 6 years in a leadership position in these areas
- Expertise and awareness of the landscape in early-stage development in the orphan disease space
- Highly developed mastery of the planning, control and monitoring of complex and highly visible drug development projects and activities
- Strong strategic thinking, ability to thrive in a dynamic, entrepreneurial, fast-paced environment
- Proven motivational leader, as well as cross-functional/global teams. Proven experience in people management, leading small and large teams including of different disciplines within the Clinical Development Organization.
- Possesses a high degree of scientific and ethical integrity. Proven ability to drive decisions and manage in difficult business situations
- Understanding of the clinical research environment and healthcare market
- Proven ability to build and maintain high value thought leader networks and professional relationships with the scientific community across a variety of therapeutic areas
- Has had a lead medical role in submissions and pre-submission interactions with regulatory agencies
- Proven experience from early to late-stage drug development studies and programs, including developing, implementing, and managing development strategy.
- Proven record of accomplishing clinical-regulatory submissions including NDA submissions.
- Thorough experience in the collaboration with Research, Clinical, Regulatory, Medical Affairs and Commercial disciplines
- Demonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities