Summary:
The Medical Director will report to the Chief Medical Officer, and will be accountable for developing
and driving the Clinical Development strategy. The Medical Director applies scientific knowledge,
along with drug development experience to ensure the clinical program and individual studies can
address clinical unmet need / improve the current standard of care for target oncology indications.
The Medical Director will be responsible for interacting with and maintaining excellent relationships
both with external Investigators as well as with internal experts to continuously optimize and refine the
Development strategy.

Responsibilities:
 Oversees clinical portfolio development from pre-IND onwards
 Oversee the design and execution of clinical trials that clearly meet the trial objectives,
oversee patient safety as well as ensuring high quality data is obtained in a timely manner
 Conduct ongoing reviews of medical/safety data, lead the development of Safety
Management Plan
 Collaborates with others in development of Statistical Analysis Plan and Data Management
Plans
 Collaborates with others in development of clinical documents adhering to ICH/GCP,
including protocols, investigator brochures, presentations and other materials
 Participates in investigator and other external presentations, meetings and other
communications
 Collaborates with relevant teams and other groups to measure and monitor study progress
against objectives and plans, including any variances, and proactively communicate any
issues and challenges to resolve
 May support clinical operations, clinical research organizations (CROs), etc. by acting as a
point-of-contact for questions, other communications, and interactions; identifying
investigators and sites

Medical degree required
 Advanced training in oncology is preferred
 Gynecologic oncology product development experience is preferred
 Minimum of 7-10 years (title commensurate with experience) of relevant clinical research
experience in the pharmaceutical, or biotechnology companies having successfully executed
a major component of a development program(s) such as reaching a go/no-go decision,
closing a study and writing a CSR, interactions with health authorities, etc
 Strong understanding of all the elements of oncology drug development preclinical and
clinical programs and experience in their design and execution
 Demonstrated experience in review, filing and defense of IND's, CTA's and full dossiers

 Demonstrated experience in successfully leading teams: 1) Running them effectively,
efficiently and on target in alignment with Departmental and Corporate goals and budgets. 2)
Capable of recognizing when team interventions are required to enhance team effectiveness
 Knowledgeable of the Commercial and Environmental issues that drive drug development
projects
 Demonstrated experience working in a matrix environment in a biotechnology or
pharmaceutical company
 Demonstrated experience in GXP (especially GCP, GLP) and experience working in a
regulated industry