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Position Details: V02004-0101: Oncology Clinician (Associate Director/Director)
| Location: | Northeast, Northeast |
| Openings: | 4 |
| Salary Range: |
Description:
Introduction:Imagine a career that touches the lives of
people everywhere. Imagine an opportunity to reach beyond your area of
expertise to make an impact on something greater than the bottom line.
Imagine playing a key role in some of the most critical issues facing
healthcare today. This is your career at a leader in the pharmaceutical space - a career unlike any
other.
Position Details:
Candidate will be responsible for working collaboratively with the clinical leader and members of the development team to establish the clinical development strategy for one or more Oncology compounds from lead development in discovery to Phase I-III clinical trials including successful regulatory submission. Responsible for trial design and supporting the final recommendations on clinical development plan including review of the pre-clinical package and biomarker strategy after soliciting appropriate input, review and endorsement from key stakeholders. Will routinely interface with discovery, safety sciences, translational medicine, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s). Will routinely focus on optimizing clinical trial design for one or more compounds and in conjunction with the clinical leader seek endorsement for go no-go development decision criteria. Will independently design protocols, amendments and conduct medical review and interpretation of efficacy and safety data from clinical trials. In conjunction with the clinical leader, will prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings. Will work with clinical leader and other extended project team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections). This individual must have proven scientific writing skills and good communication skills as well as expertise in clinical oncology. Role will involve liaison with many internal groups, including internal governance, commercial and external experts and potentially regulators. May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues including mentoring in Oncology. Level to be based upon experience.
Position Details:
Candidate will be responsible for working collaboratively with the clinical leader and members of the development team to establish the clinical development strategy for one or more Oncology compounds from lead development in discovery to Phase I-III clinical trials including successful regulatory submission. Responsible for trial design and supporting the final recommendations on clinical development plan including review of the pre-clinical package and biomarker strategy after soliciting appropriate input, review and endorsement from key stakeholders. Will routinely interface with discovery, safety sciences, translational medicine, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s). Will routinely focus on optimizing clinical trial design for one or more compounds and in conjunction with the clinical leader seek endorsement for go no-go development decision criteria. Will independently design protocols, amendments and conduct medical review and interpretation of efficacy and safety data from clinical trials. In conjunction with the clinical leader, will prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings. Will work with clinical leader and other extended project team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections). This individual must have proven scientific writing skills and good communication skills as well as expertise in clinical oncology. Role will involve liaison with many internal groups, including internal governance, commercial and external experts and potentially regulators. May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues including mentoring in Oncology. Level to be based upon experience.
Qualifications:
- EDUCATIONAL BACKGROUND: MINIMUM: MD with subspecialty training in oncology and demonstrated
depth and breadth of knowledge and experience in oncology research in
the academic, oncology clinical practice or industry setting.
- DESIRABLE: Industry experience in Oncology; Good understanding of cancer research/oncology drug development required and academic or industry experience in cancer research or translational medicine desirable.
- WORK EXPERIENCE/SKILLS: MINIMUM: Demonstrated scientific productivity (publications,
patents, abstracts, research reports etc.). Requires ability to work
across many interfaces in a highly matrixed environment.
- DESIRABLE: Experience in Oncology clinical drug development and oncology clinical trial design, translational medicine and medical conduct with industry experience preferred. Keen interest in novel targeted therapeutic development and biomarkers desired.
- OTHER ATTRIBUTES DESIRABLE: Strong clinical trial and drug development experience in Oncology and ability to medically execute multinational projects preferred.
Client 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. Client also 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.
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