Senior Director, Clinical Development

ChemoCentryx is searching for a Senior Director, Clinical Development that will provide medical input to global clinical programs as a member of the Core team, serve as the medical expert for the study team and medical monitor for phase 1-4 clinical trials, as applicable.  The Sr. Director will report to the SVP, Clinical Development and will our out of our corporate center in San Carlos, CA.  

Essential Duties and Responsibilities

• Provide medical leadership for assigned clinical development programs
• Partner with Clinical Operations to develop clinical development plans (CDPs) and co-lead the clinical subteam to execute the CDP(s)
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
• Contribute to activities in support of the company’s regulatory submissions, including authoring clinical sections for INDs, NDAs, and other related documents
• Partner with pharmacovigilance to best understand the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
• Maintain ethical standards of the highest level, with an absolute commitment to comply with all relevant ethical, regulatory, and legal strictures and the associated learnings thereof
• Lead/participate in clinical research due diligence in support of business development activity
• Interface with relevant functions (e.g. discovery, preclinical development, regulatory, clinical operations, etc.) to design and execute clinical development plans for assigned projects
• Provide medical information on existing and emerging data, in response to questions from internal and external stakeholders

Requirements

• MD or equivalent degree; completion of residency training with 8 years of industry experience in clinical development with 4 years in leadership position
• Global experience in drug development as well as post-marketing setting
• Experience with global regulatory filings
• Excellent organizational and prioritization skillset
• Ability to work independently and as part of the wider cross functional team
• Strong interpersonal skills including verbal and written communications
• In depth knowledge of  relevant FDA, EMA,  and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines

Preferred Experience

• Experience working with rare disease states