Associate Medical Director/Medical Director, Clinical Development (Job Code #AMDCD)

FLX Bio is a biotechnology company focused on the discovery and development of novel drugs that will improve and prolong the lives of people with cancer. The company is led by a group of seasoned researchers from the biotechnology and pharmaceutical industries and is supported by several of the nation’s premier life sciences venture capital firms as well as by Celgene. The company is located in the San Francisco Bay area, in the heart of the world’s largest biotechnology research hub. We offer a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants.

POSITION SUMMARY   

The Associate Medical Director/Medical Director will report to the CMO and will be responsible for the design, execution, monitoring, analysis, and reporting of Phase I/II clinical studies, with an initial focus on novel cancer immunology agents. This physician scientist will provide clinical and development expertise and will work closely with cross-functional teams to align the clinical development plan with the overall development strategy of the program.

ESSENTIAL FUNCTIONS

  • Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports
  • Provide strategic and design input for clinical trials and clinical development plans
  • Preparation, design, and/or review of clinical documents, e.g. protocols, investigator’s brochures, case report form design
  • Participate in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits
  • Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)
  • Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators
  • Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
  • Review serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with the CRO to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs
  • Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
  • Represent the company at scientific meetings and presentations
  • Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
  • Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
  • Develop and manage relationships with key opinion leaders for clinical programs

 EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS 

  • M.D. or M.D./Ph.D., with board certification or eligibility in oncology or hematology/oncology required
  • Minimum of 3 years’ oncology clinical trial experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience
  • Experience with clinical trial design, conduct, and medical monitoring
  • Knowledgeable and current in GCP guidelines in US and Europe
  • Be well connected within the medical and scientific community and have a proven successful track record
  • Hands-on experience with clinical trial strategy, methods and designs
  • Ability to work proactively and effectively, with exceptional creative problem-solving skills
  • Excellent strategic planning, organizational and communication skills
  • Up to 20% travel