Director, Clinical Development/Operations Corium International
The Director, Clinical Development/Operations - The incumbent will have hands-on responsibility in designing and executing clinical trials working with external CRO's and medical therapeutic area experts, and running programs focused on relevant therapeutic areas, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. The clinical drug development will pertain primarily to reformulation of existing drugs and biologics using Corium drug delivery technologies and administration by transdermal/ oral mucosal routes of administration. The Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study.
Lead planning and execution of local or global clinical studies, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines
Demonstrates advanced knowledge of design and phases to support 505(b)(2) or equivalent clinical studies on a global scale, CRO operations, and compliance practices.
Effectively selects, qualifies, oversees, manages, and influences CROs, and builds strong relationships at the senior levels within the CRO organization.
Validates the study implementation plan provided by the CRO through to study close out and Clinical Study Report (CSR) writing. Actively assess potential risks to the study and propose mitigation plans
Supervises all study activities with the clinical study team members in terms of study initiation, monitoring, data collection activities, and site management up until finalization of CSR and medical writing tasks (IB, protocol development, ICF, CRF guidelines, safety communications, IND, etc.)
Responsible for management of CRO(s) performance to ensure adherence to scope of work within protocols, timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study
Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work and budget
Develop relationships with key therapeutic area medical experts and thought leaders to support product development and represent Corium externally in applicable scientific and medical forums
Interface with regulatory authorities directly as appropriate (e.g. FDA panel meetings, BIMO audits, etc.)
Provide senior management with the necessary reports on progress and changes in scope, schedule and resources in a timely manner including preparation of presentations and documents
Provide strategic input and direction to organization for publications, presentations, investigator meetings and other public forums in which clinical data is presented or interpreted.
Minimum education: MD or PhD or PharmD in relevant discipline e.g. clinical pharmacology
Minimum experience: 10 years designing, leading and managing clinical science/operations/ development in a pharmaceutical and/or biotechnology company demonstrating a broad background in those environments; experience in drug delivery space, 505(b)(2) pertinent clinical study designs and execution, and substantial experience working on industry-sponsored trials will be preferred
Experienced manager with proven ability to interact with and train clinical monitors and physicians investigators, and build constructive, trusting and respectful relationships with individuals at all levels both internally and externally
Extensive prior experience managing Phase 1 and 2 CNS, endocrinology, urology trials will be preferred
Knowledge of key opinion leaders and medical experts in the areas of endocrinology, CNS and urology is desirable
Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
Familiar and comfortable with clinical concepts, practices and FDA and international regulations regarding clinical research trials
Familiar with data processing methods, general knowledge of clinical medicine and medical terminology
Possess strong critical thinking and problem solving skills
Excellent leadership, performance management, communication, and organizational skills
Ability to manage the needs of multiple internal and external partners and deploy resources to meet those needs
||235 Constitution Drive |
Menlo Park, CA 94025