Posted on August 1, 2007 by PRN.

Associate Director / Director: Oncology or Infectious Disease Clinician

• Work 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 support final recommendations on the clinical development plan, including review of the pre‑clinical package and biomarker strategy after soliciting appropriate input and obtaining endorsement from key stakeholders.

• Interface routinely with discovery, safety sciences, translational medicine, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s).

• 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.

• Independently design protocols, amendments and conduct medical review and interpretation of efficacy and safety data from clinical trials.

• Prepare strategy presentations, present and discuss data at relevant team meetings, governance meetings, external consultant meetings, KOLs and, potentially, regulatory meetings.

• Co‑author abstracts, manuscripts and presentations for external meetings and author clinical sections of regulatory documents (IB, Annual Reports, IND sections).

• Maintain excellent scientific writing and communication skills and demonstrate expertise in clinical oncology; may have functional responsibility for other clinicians assigned to the project and may supervise and mentor colleagues.

Education Background: MD with subspecialty training in oncology; good understanding of cancer research.

If you are interested in these positions, please email a cover letter and CV to info at prn resource.com, and we will forward it to the executive search firm looking to fill the positions.