Director, Clinical Development (MD)

The Company:

Our mission is to improve the lives of people impacted by cancer by developing and commercializing innovative cancer therapies. We know how a cancer diagnosis affects a person and their family, and we are driven every day to improve outcomes for those who have received the diagnosis. We do this by driving adoption of our first FDA-approved breakthrough drug for appropriate patients with extensive-stage small cell lung cancer and by developing our robust, late-stage clinical pipeline assessing the potential for our medicine in a variety of tumors and cancer treatment settings.

Our strategy leverages the experience of the G1 team and our deep experience in inventive and responsible drug development and commercialization. G1 provides a professional, diverse, inclusive, and creative working environment where individuals can thrive. We are driven to succeed by the patient communities we seek to help. We offer an opportunity to bring your best every day, and in doing so, profoundly help people living with cancer. Patients are waiting.

The Opportunity:

G1 Therapeutics is currently recruiting a Director of Clinical Development (MD or equivalent) to join our team remotely or in our RTP offices, reporting to our VP of Clinical Development. In the role of Director of Clinical Development, you will be responsible for the design, medical oversight, and interpretation of clinical studies and clinical development strategy in collaboration with a cross functional team.

To be successful in this role, you must have a broad understanding of pharmaceutical drug development and the ability to think critically and manage complex situations with agility. Successful cross functional collaboration and effective communication skills are essential.

Responsibilities:

• Providing scientific and medical expertise to the design and implementation of phase I-IV clinical studies to drive successful global filings.

• Providing strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment.

• Author/review clinical documents such as protocols, Investigator’s Brochures, informed consent forms, DSURs, etc.

• 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.

• Responsible for clinical development plans and overall strategy for assigned compounds while taking into consideration ongoing developments in the area of clinical oncology and oncology drug development.

• Collaborate cross functionally with clinical scientists, translational sciences, regulatory, biometrics, clinical operations in development of study protocols, clinical development strategy, and implementation of clinical strategy.

• Build and maintain solid working relationships with key opinion leaders and lead clinical investigators.

• Oversee planning and management, including preparation of presentation materials, 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 sNDA applications.

• 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.

• Other duties as assigned

Requirements:

• MD or equivalent required

• 5+ years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical, or CRO environment

• 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; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams

• Excellent written and verbal communication skills required

• 15-20% travel

Why Join Us?

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.

An Equal Opportunity Employer

G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

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