Senior Director, Clinical Scientist
Employment Type : Full-Time
The Company:
G1 Therapeutics is a clinical-stage biopharmaceutical company focused on discovery, development, and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies. Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer who are treated with chemotherapy. A New Drug Application (NDA) for trilaciclib has been assigned Priority Review by the FDA, with an action date of February 15, 2021. G1 is also advancing rintodestrant, a potential best-in-class oral selective estrogen receptor degrader, or SERD, for the treatment of ER+ breast cancer. In 2020, G1 out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.
The Opportunity:
G1 Therapeutics is currently recruiting a Senior Director, Clinical Scientist to join our team, reporting to the VP, Clinical Development. This position is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams to ensure the timely execution of the clinical development plan.
To be successful in this role you will require minimal supervision from the medical director in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data. You will collaborate with Clinical Operations in the overall conduct and timely execution of clinical trials, and work in collaboration with other key stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.
NOTE: This position is currently remote based, with flexibility to remain so at a future date when we resume normal business practice at our HQ office in RTP, North Carolina.
Responsibilities:
- Author key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, investigator’s brochures, annual reports and clinical sections of regulatory submissions
- In conjunction with clinical operations team, participate in selection of investigators, clinical sites, and vendors (including CRO)
- Accountable for the clinical/scientific execution of the clinical protocol.
- Accountable for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders (e.g., investigator meeting presentations, data review and summary, protocol deviation review, etc.)
- Create and maintain clinical development plans to be aligned with Target Product Profile
- Develop and perform clinical data review plans for clinical studies
- Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.
- Builds relationships with external scientific and clinical thought leaders
- Author abstracts and prepare posters for external presentation
- Establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems (eCRF), and final reports
- Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.
- Able to work independently as well as contribute as part of an interdisciplinary team
- Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes
- Leads mentorship of newly hired clinical scientists
Requirements:
- BSN, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred with strong scientific knowledge and skillset
- ? A minimum of 14+ years’ experience in the pharmaceutical industry, with minimum 5-8 years clinical development/clinical operations experience in oncology?
- Requires thorough understanding of the drug development process from pre-IND through registration and post-registration?
- Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management
- ?Candidates must possess highly effective communication skills and be fluent in the English language, both written and verbal.
- ?Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust overall clinical development strategy
- ?Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader
- ?Ability to work independently and to organize priorities and deliverables
- The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
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