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Director, Clinical Development

  • Location: South San Francisco
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 14 days ago

  • Sector: Life Sciences
  • Contact: Divna Rosenzweig
  • Expiry Date: 17 December 2022
  • Job Ref: JN -112022-475094



Medical Director, Clinical Development

We are seeking a driven and talented individual to join our clients Clinical Development team as they change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing their novel therapeutics. They are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.




The Director, Clinical Development will report to the VP of Clinical Development and will be responsible for the design, execution, medical monitoring, data analysis, working with safety for study safety oversight, and help with preparation of regulatory documents including a BLA filing of a Phase 2 registration-directed clinical study. The role is as a lead medical monitor for a registration study and will work closely with the VP of Clinical Development. This physician scientist will provide clinical and development expertise and will work closely with cross-functional teams to execute on the conduct, analysis and filing of data from a registration study. In addition, the Director will work as part of the clinical team in executing and contributing to the development strategy of the compound.



Responsibilities

  • Serve as the lead Medical Monitor for a phase 2 or 3 clinical registration trial to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) medical monitors or directly with study investigators and coordinators
  • Lead medical monitor for a Phase 2 or 3 registration study with oversight of CRO medical monitors
  • Provide clinical input into study design and implementation as a lead clinical representative on the study
  • Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports
  • Work with clinical operations to drive and support study enrollment
  • Work with data management, clinical scientists, clinical operations and biostatistics on data cleaning in preparation for formal study analyses or for regulatory document updates
  • 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 visits and engagement calls
  • Contribute as an authoring of clinical sections of relevant regulatory filings (IND, study reports, etc.)
  • Participate with Safety to 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
  • Represent the company at scientific meetings and presentations
  • Participate in study investigator meetings
  • Support study outreach and medical affairs activities
  • Contribute to scientific affairs with 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
  • Provide clinical oncology input to internal early-stage project teams

Qualifications

  • M.D. or M.D./Ph.D., with board certification or eligibility in oncology or hematology/oncology preferred
  • 8 plus years of experience with a minimum of 3 years of oncology clinical trial experience in pharmaceutical or biotech industries preferred
  • Experience with clinical trial design, conduct, and medical monitoring
  • Participation as a medical monitor on a registration study
  • Knowledgeable and current in GCP guidelines in US and Europe
  • 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 25% travel (US and international)

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