Other Locations:US- CA- San Francisco- Owens Street Celgene
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Director, Clinical Research Science, Hematology/Oncology Translational Development (TD) leads the tactical efforts for early development clinical trials from a clinical science perspective. The incumbent works collaboratively with the clinical research physician (CRP), who is responsible for clinical trial oversight as well as leadership and implementation of the overall development strategy for hematology/oncology, early clinical stage compounds. The incumbent is accountable for working closely with the global project and study teams to optimize efficiency and quality around tactical deliverables, including IND/CTA and other regulatory submissions, study protocol/amendments and supporting clinical trial documentation (eg. informed consent forms, case report forms), clinical data quality assurance, clinical trial site interactions/updates, study reports and peer-reviewed publications.
This position involves participation in a minimum of two studies/programs of varying complexity and requires active engagement with key internal stakeholders, including the CRP, clinical and TD operations personnel, translational research (TR) scientists, TD and project/team leadership, and cross-functional counterparts in data management and biostatistics, regulatory affairs, drug safety, medical writing, clinical pharmacology/clinical quality assurance (CQA), preclinical toxicology and CMC. Additionally, the incumbent must be able to effectively engage with key external stakeholders including clinical trial site personnel.
This position receives minimal supervision from the TD CRP(s) and may be required to assume performance management/career development responsibilities for level II (CRS) and/or level III (Sr. CRS) personnel.
Specific Responsibilities include, but are not limited to, the following:
- In collaboration with the CRP, represents Translational Medicine in cross functional teams (eg. transition teams, global project teams, study teams, safety review committees, etc.); capable of standing in for the CRP on occasion and in specific contexts
- Contributes to the creation of the early clinical development strategy pre-development candidate (DC) nomination (in the context of translation team deliberations) and post-DC nomination (in the context of global project team deliberations)
- Leads the authorship/review and amendment of clinical study protocols, consent forms, case report forms and other clinical study documents in collaboration with the CRP and cross-functional study team members
- In collaboration with data management/clinical programming counterparts, oversees the preparation of a clinical data review plan (CDRP) that outlines the process and timelines for and contributors to the generation of clinical data deliverables (eg. data tables, figures, listings, patient profiles) for Celgene-sponsored early development studies
- Coordinates with clinical operations personnel (ie. study managers, CRAs), data management, the CRP and drug safety manager/physician in the review, querying and reconciliation of clinical data both in real-time and prior to database extraction
- Leads the preparation and interpretation of data summaries for presentations at Safety Review Committee meetings, Early Development Advisory Committee (EDAC) meetings, Candidate Development Committee (CDC) meetings, Quarterly Research Review meetings and other internal meetings in collaboration with the CRP and TR scientists.
- Leads the preparation of abstracts, posters, oral presentations and manuscripts for purposes of peer-review and reporting of results from Early Development clinical trials at various external meetings (eg. ASH, ASCO, EHA, ESMO), in collaboration with the CRP and TR scientist
- Functions in a technical support role (ie. as study protocol and subject matter expert) for study managers, CRAs and study site personnel in the day-to-day conduct of clinical studies
- Assists in troubleshooting questions/challenges confronted by functional and cross-functional peers; successfully manages conflicts/issues to resolution and with an outcome of improved team collaboration
- Partners with TM/CRS peers and cross-functional counterparts (eg. via Project Velocity initiatives) to improve efficiency, quality and consistency of clinical trial execution across Early Development, including: 1) maintenance of TD protocol templates, 2) development of more efficient processes for protocol development and amendments, 3) improved processes to optimize efficiency of subject screening and enrollment, 4) improved methods for data capture, review, compilation and analysis.
- Responsible for managing Level II and/or Level III CRSs including development training, performance management, goal setting, etc
- Actively contributes to preparation of the agenda and meeting contents for TD advisory board and investigator meetings; delivers presentations of selected topics at investigator meetings
- Bachelor’s degree with a life sciences concentration plus an advanced degree (MD, MS, PharmD or PhD) in a relevant field required. Ph.D. with at least 10 years of related experience is preferred.
- Eight or more years of academic and/or pharmaceutical/biotech industry, clinical research & development experience
- Proficiency in malignant hematology and oncology disease states as well as concepts of cancer biology is required
- Proficiency in clinical study protocol, informed consent, case report form design and clinical study report writing
- Proficiency in clinical data interpretation and analysis
- Working knowledge/understanding of basic statistical concepts and commonly used biostatistical methods in early clinical trial.
- Working knowledge/understanding of the regulatory landscape in key geographies
- Demonstrates leadership capability as well as strong planning and organizational, written and oral communication skills
- Proficient in the use of industry-standard software (eg. Microsoft Office Suite, WebEx, Medidata RAVE; RAVE X, etc)
- Established track record of effective interactions with clinical trial site personnel, including the ability to manage potential conflicts with external partners
- Domestic and international travel, as required
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.