G1 Therapeutics
  • Durham, NC, USA
  • Full Time

G1 Therapeutics is seeking an experienced Associate Director, Clinical Development to join the team.  This MD must have oncology experience.

Job Responsibilities: 

  • Oversite of CRO medical monitors with primary sponsor responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
  • Primary responsibility for design and implementation of applicable clinical protocols, data collection systems, and final reports.
  • Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds, or specific indications while taking into consideration ongoing developments in the area of clinical oncology and oncology drug development.
  • Collaborate with pre-clinical, translational sciences, regulatory, and senior management in development of study protocols, clinical development strategy, and implementation of clinical strategy.
  • Provide leadership on cross-functional product development team(s) as experience allows.
  • Participate in identification, selection and conduct of negotiations with clinical research centers and investigators.
  • Participate in the selection and management activities of CROs.
  • Supervise project team members in planning, conducting and evaluating clinical trials.
  • Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
  • Partner with development team leads to formulate strategy and coordinate cross-functional planning and execution across multiple indications.
  • Participates with clinical development in all aspects of NDA and ANDA applications.
  • Partner with direct manager and other members of the Clinical Development Leadership Team to facilitate governance and/or clinical development organizational meetings.
  • Engage with stakeholders at all levels of the organization to solicit input and feedback. Incorporate learnings into team direction setting, problem resolution and lessons learned activities.
  • Motivate and facilitate informed, timely, and impactful decision making across the organization.
  • Develop and maintain a high performing operational approach including effective team building and conflict management. Identify situations requiring escalation.

Requirements:

  •  MD required
  • 2+ years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical, or CRO environment if oncology board certified/eligible OR 5+ years of experience in the pharmaceutical industry in a clinical development role if physician has oncology experience but is not oncology board certified/eligible
  • Oncology experience required
  • Experience with the clinical drug development process
  • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents
  • Ability to handle complexity, prioritize and multi-task current project demands. Must be able to prioritize and deliver effectively with minimal supervision
  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
  • Ability to make sound and timely decisions; agile in learning and action oriented
  • High level of emotional intelligence; able to deal with ambiguity
  • Able to relate to varied level audiences across the organization

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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