Head of Clinical Development /
Senior MEdical director
The Head of Clinical Development / Sr. Medical Director will lead and help take ownership of one or more of our progressing clinical trials while providing strategic direction, leadership and medical expertise to our growing clinical development team.
Reporting to the Chief Medical Officer, this role provides the opportunity for the right candidate with superior protocol writing, medical monitoring and KOL interaction skills and experience with the opportunity to truly make an impact on the lives of patients and future success at Karuna.
Roles and Responsibilities
While working closely with CMO, maintains overall accountability for design and implementation of clinical studies, writing clinical protocols and major amendments, design of data collection systems and preparation of final clinical study reports.
Provides medical input to overall development planning and implementation.
Responsible for driving and implementing clinical development plans.
Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support.
Responsible for directing human clinical trials, Phases I – IV, for company products under development.
Engages with KOLs for design of clinical trials and programs.
Direct involvement in study related meetings, both internal and external
Collaborates in identifying qualified investigators and institutions
Collaborates on the analysis and interpretation of the results of the trials
Key contributor to regulatory strategies and authors and/or reviews appropriate regulatory documents.
Coordinates and develops information for reports (particularly the medical sections) submitted to regulatory authorities.
Lead safety surveillance, risk management and risk communication activities including medical reporting and assessment of adverse events
Accountability to maintain the assessment of benefit/risk.
Develop risk management profiles
Review and provide medical/safety input of PBRER, DSUR, clinical expert statement, etc.
Ensure that safety risks with projects, programs are rapidly identified analyzed and reported
Develop and direct overall drug safety operations processes to insure compliance with regulatory requirements U.S. and International health authorities.
Collaborate with external consultants, investigators, and opinion leaders to ensure the Company’s strong reputation in the community.
Experience, Education and Specialized Knowledge and Skills
The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Must excel in a multidisciplinary environment as an integral leader and team member across project and portfolio teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.
Specific requirements include but are not limited to:
Medical degree and 7+ years broad bio/pharmaceutical industry experience in drug development.
IND submission and maintenance experience preferred. NDA experience a plus.
Knowledge of Neurology and/or Psychiatry preferred.
Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues.
Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Able to command respect from peers and subordinates alike, capable of highly-independent work as well as being a team player and role model.
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company.
Ability to work independently as well as part of a team environment.
Proven ability to manage multiple projects, identify and resolve issues.
Must be able to solicit information, persuade others and shape outcomes.