Job Category: Clinical: Clinical Operations and Development
Job Number: 2027
Our client is seeking a Medical Director to oversee the planning and execution of clinical trials and the interpretation of clinical trial data. The successful candidate will be responsible for successful execution against agreed clinical development plans.
To be successful in this role, the individual will be self-motivated, must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines. The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with contract research organizations, academia and nonprofit organizations.
Roles and Responsibilities
- Contributes to the design and leads the execution of clinical studies, including writing clinical protocols and major amendments, designing of data collection systems and preparation of final clinical study reports.
- Represents Medical Science on assigned Study Management Team(s) as the Study Medical Lead, providing medical input to all aspects of clinical trial execution.
- Participates in the Clinical Sub Team, as directed by the Program Medical Lead.
- Responsible for providing or supervising medical monitoring activities for all human clinical trials, Phases I– IV, for company products under development.
- Responsibilities also include support of adverse event reporting and patient safety.
- Provides medical information for inclusion in reports submitted to regulatory authorities.
- Supports the authoring of appropriate regulatory documents.
- Engages with KOLs for the design of clinical trials.
- Contributes to the assessment of benefit/risk
- Ability to manage external organizations.
- Medical degree and 2-5 years broad bio/pharmaceutical industry experience in drug development or equivalent. Industry and/or IND experience strongly preferred.
- Knowledge of Neurology, Anesthesia and/or Psychiatry.
- Orphan drug/fast-track experience desirable.
- Knowledge of the drug development process
- Strong understanding of technical, business, and regulatory issues.
- Diplomacy and professionalism, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicines to patients.
- Able to effectively interface with clinical operations and other disciplines.
- 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.
- Ability to influence without authority, lead change and manage resistance to change.
- Must be able to solicit information, persuade others and shape outcomes.
- Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs.