Medical Director- Boston, MA
Our client is developing a therapeutic option that will change how over 20 million people who suffer from neurological issues will be able to live. They are currently looking for a Medical Director to join their team.
The Medical Director will be responsible for assisting with the advancement of several key clinical trials. Reporting to the Chief Medical Officer, this role provides the opportunity for the right candidate with CNS experience, superior protocol writing, medical monitoring, and KOL interaction skills to truly make an impact on the lives of patients and the future success of the company.
Roles and Responsibilities:
- Maintain the overall accountability for the design and implementation of clinical studies, writing clinical protocols and major amendments, design of data collection systems, and preparation of final clinical study reports.
- Provide 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 and developing protocols for human clinical trials, Phases I – IV, for company products under development.
- Engage with KOLs for the design of clinical trials and programs
- Direct involvement in study-related meetings, both internal and external
- Collaborate in identifying qualified investigators and institutions
- Collaborate on the analysis and interpretation of the results of the trials
- Contribute to regulatory strategies and authors and/or reviews appropriate regulatory documents.
- Coordinate 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
- Accountable to maintain the assessment of benefit/risk.
- Develops risk management profiles
- Reviews and provides medical/safety input of PBRER, DSUR, clinical expert statement, etc.
- Ensure that safety risks with projects, programs rapidly identify, analyze, and report.
- Develop and directs overall drug safety operations processes to ensure 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.
Specific requirements include but are not limited to:
- Medical degree and 5-7 years broad bio/pharmaceutical industry experience in drug development.
- Knowledge of Neurology and/or Psychiatry highly preferred.
- IND submission and maintenance experience preferred. NDA experience a plus.
- 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.
Please contact Earl at firstname.lastname@example.org for consideration.