The Clinical Development Department at ChemoCentryx is seeking a Senior Medical Director who will be responsible for providing clinical leadership of clinical development programs, and for the design, execution, and analysis of clinical trials, as well as for supporting Medical Monitoring activities across trials. An MD degree is preferred; a degree of PharmD or PhD with equivalent experience and skills will also be considered. The Senior Medical Director will report to the VP of Clinical Development and Translational Medicine and will collaborate with other medical officers in the organization.
The Senior Medical Director has proven leadership skills and the ability to successfully guide and influence cross-functional teams. The individual collaborates with internal stakeholders such as Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Data management, Biostatistics as well as with external collaborators such as study investigators and their staff, Key Opinion Leaders, CROs and vendors operating on behalf of ChemoCentryx. The candidate will be able to work in a highly scientific and vibrant, fast-pace clinical research environment at an organization that is undergoing substantial growth, and have the opportunity to get exposed to a wide spectrum of clinical pharmaceutical development activities including the opportunity to support regulatory submissions such as an NDA.
Essential functions and responsibilities include the following:
- Leads project team strategy, scope, complexity, size, and deliverables, overseeing the development strategy, clinical development plan.
- Leads the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
- Directs, designs, authors and reviews clinical trial protocols, protocol amendments, informed consent documents, investigator brochures, CRFs, monitoring plans, data and statistical analysis plans, etc.
- Authors and reviews sections of clinical study reports and regulatory submission documents, such as, INDs, CTAs, NDAs, MAAs, regulatory agency briefing packages, etc.
- Supports the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
- Responsible for the scientific execution as required for the initiation, conduct and medical monitoring of Phase 1-3 clinical trials
- Prepares, presents, and defends complex aspects of protocol design and/or medical study data at internal meetings or investigator meetings
- Actively engages in the planning, preparation and participation of regulatory meetings, e.g., Pre-IND-, End-of-Phase 2 meeting, or other regulatory meetings
- Collaborates with external stakeholders such as study investigators and their staff, Key Opinion Leaders, CROs and vendors during all phases of the clinical trial and program.
- Prepares and reviews draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators
Required Education and Experience
- Proven leadership skills and ability to successfully guide and influence cross-functional teams.
- Requires an MD degree with a minimum of 8-10 years of pharmaceutical/biotech industry experience. PhD or PharmD with equivalent experience and skills will also be considered.
- Ability to develop and conduct complex clinical research programs independently. Has advanced the development strategy of clinical programs including pivotal clinical trials (Phase I-III).
- Will be able to develop, author and review Clinical trial protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, Safety Monitoring Plans, Development Safety Update Reports, and other regulatory documents
- Has robust expertise in the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
- Will be able to evaluate safety events (e.g. SUSARs, laboratory observation, etc.) and analyze in conjunction with similar events across clinical trials and programs. Will be able to closely collaborate with the Safety and Pharmacovigilance group and Medical Monitors at the CRO.
- Experience in one or more of the following clinical area(s) is desirable but not a must: Immunology, oncology, nephrology, and rheumatology. Prior medical practice is a definite plus.
- Deep understanding of Good Clinical Practices (GCPs) is necessary. Has successfully conducted clinical trials in a GCP/ICH compliant environment
- Has demonstrated the ability to analyze, interpret, and present complex scientific clinical data to both subject matter (e.g. key opinion leaders) and non-subject matter experts and is able to draw medical and scientific conclusions
- Has demonstrated solid understanding of biostatistics, trial planning and sample size generation in collaboration with the biometrics group
- Has basic understanding of clinical pharmacology
- Has worked directly with Clinical investigators and is able to provide leadership in protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators and investigator trial staff
- Has demonstrated scientific expertise in the presentation and publication process with a track record of publishing peer-reviewed scientific data, e.g., posters, oral presentations, review articles, and manuscripts
- Can work well in a cross-functional team environment which includes representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
- Has outstanding ability to present and communicate medical or scientific clinical data in a clear and concise manner
- Has excellent business presence and demonstrated the ability to build/maintain relationships with internal and external stakeholders
- Track record of creativity, high performance, and demonstrated ability to work independently and meet deadlines in a dynamic, fast-pace work environment and deliver the highest standard of quality work.
- Excellent verbal and written skills along with the ability to work collaboratively in a dynamic and creative environment is essential
We participate in E-Verify, the US Government sponsored right-to-work verification process.