Director/Senior Director
La Jolla, CA

JOB SPECIFICATION

The Company

The Company is a venture-backed company focused on the development of potent, selective small molecule inhibitors of the PI3K/Akt/mTOR pathway for the treatment of cancer, inflammation and autoimmune disorders.
Our founders, management team, and advisors include experts in research and early development of drugs against this important family of targets. In addition, we work with leading clinical experts in the diseases we intend to evaluate.

The Position

We are seeking a Director/Senior Director, hematologist/oncologist to join our biotech company focused on the development of small molecule inhibitors of the PI3K/mTOR pathway. The successful candidate will provide clinical oversight for one or more projects and will join a team of leading experts focused on developing novel compounds for the treatment of cancer. The Director/Senior Director will work with colleagues across the company to plan, develop, design, and implement clinical early development (Phase I/II) trials. Additionally, the candidate will have accountability for medical monitoring, analysis, and reporting of studies. These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies.  

The position will report to the Chief Medical Officer.

Professional Responsibilities

• Provides project clinical oversight; develops plans, designs, and implements clinical trials along with candidate biomarker/diagnostic strategy.
  Develops and works on documents such as IND, Investigator Brochure, Safety Reports, Clinical Protocols, Study Reports, Annual Reports, Scientific publications and Presentations as needed.
• Partners with Clinical Operations, Biostats, Regulatory and Pre-clinical functional representatives as part of project team
• Participates in the identification of appropriate external investigators
• Stays abreast of internal and external developments (scientific, clinical, regulatory) and integrates this information in terms of its impact on the company’s portfolio. Includes attendance at major scientific conferences, participation in competitive intelligence activities and projects, and review of published scientific and clinical literature
• Ensures clinical programs are in compliance with all regulatory requirements; participates in FDA or other health authority interactions

Candidate Qualifications

The candidate should have an M.D. with board certification or board eligibility in hematology/oncology. Industry experience, including early development experience and management and monitoring of phase I clinical trials, is required. Minimum of 5 years industry or comparable experience required. The candidate must have the willingness and expertise to work within a multi-disciplinary team of peers and outside experts. Experience with early clinical trials, data analysis and interpretation as well as an understanding of pharmacovigilance principles required. Versed in medical aspects of FDA regulations. Has built relationships with a number of important external constituents: possibly including clinical and/or research experts, advocacy groups and NCI. Business travel is required.

Required Skills and Abilities

The successful candidate must be/have:

• Highly motivated and have outstanding attention-to-detail, particularly in terms of medical monitoring
• Working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial, etc.
• Can prioritize multiple tasks and goals and ensure that activities are timely, on-target and within-budget
• Good interpersonal, verbal communication and influencing skills
• Strong written communication skills
• Good clinical and scientific presentation skills, both internally or externally
• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
• Good judgment and decision-making skills; works well within teams
• Is committed to developing drugs that will make a difference in the life of patients