This Executive Medical Director is responsible for generating clinical development strategies and plans, covering phases from preIND to registration and overseeing the direction, planning, execution, and interpretation of clinical trials and data collection. Seniority of the position will be based on previous experience.
- Designs and manages clinical development projects, including working cross-functionally with all disciplines necessary for successful drug/therapy development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, clinical operations and program management
- Identify, interact and build collaborative relationships with key opinion leaders and academic organizations to assure incorporation of latest methods and guidelines into clinical development plans
- Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies
- Leads the Clinical Development Plan creation and maintenance for the covered projects and indications, with a clear vision for how to enable data driven decisions (prioritization, Go/NoGo) in the context of the portfolio
- Directs protocol implementation including supporting the creation and reviewing key documents, site identification and communication, attendance and presentation at investigators’ meetings, correspondence with sites including IRBs and interaction with operations teams
- Monitors clinical trials including data review and querying (patient profiles, data listings, other clinical outputs) in collaboration with data management, and oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
- Leads, with the support of the clinical scientist, the Steering Committee and DSMB meeting preparation, presentation and results implementation (as applicable)
- Reviews safety and efficacy data, leads the study team through analysis and interpret the study results, and make recommendations as to appropriate next steps. Monitors and explores data in real-time and is able to summarize and present current status on short notice.
- Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
- Interacts closely with Medical Affairs in support of ISTs and publication strategy and plan, acts as owner of clinical data as member of publication team
- Supports commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team
- Interacts closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies
- Hire, retain and manage clinical scientist/s and engage and inspire the teams through communication of strategic plans and vision
Education and Qualifications
- Board Certified MD with 10+ years of industry experience
- Subspecialty training in oncology preferred
- Outstanding academic achievement and significant clinical trial experience preferred
- Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
- Experience in leading clinical development programs within a research-driven pharmaceutical or biotech company.
- Track record of leading projects through successful clinical development, registration and launch.
- Demonstrated independence, initiative and the ability to work well in a fast-paced environment
- Experience managing resources and budgets
- Keen ability for creative problem solving in executing project objectives.
- Demonstrated people management and cross functional collaboration skills by proven accomplishments on previous manager and (matrix) leadership roles.
- Proven leadership skills including managing, developing and mentoring direct reports.
- Travel time is approximately 15% to 25% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings
- Sit for an extended time in front of a computer