Director, Oncology Clinical Development in San Diego, CA

$150K - $200K(Ladders Estimates)

Halozyme Therapeutics, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 43 days ago

POSITION SUMMARY:

The Director, Oncology Clinical Development will be accountable for working within a multi-disciplinary core team to develop and manage Halozyme's oncology clinical trials in one or more tumors. This individual will contribute clinical expertise and strategic insight to the Development Sub-Team (DST) to help shape the overall development strategy for Halozyme's lead asset, PEGPH20, and for Halozyme's anticipated expanded oncology portfolio.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:


  • Serve as the Halozyme medical monitor for Phase 1, 2 and/or 3 clinical trials including studies in pediatric populations
  • Plan, analyze, report and publish Halozyme sponsored clinical trials
  • Work with Clinical Operations, Medical Affairs and the CRO to support patient recruitment and the execution of each assigned study
  • Work with the Halozyme Safety team to provide integrated pharmacovigilance for the study
  • Work with a multidisciplinary team on data cleaning and database lock activities
  • Work with partner functions (Quality, Regulatory and Safety) to provide quality and compliance oversight of the study
  • Work with the Translational Medicine and Patient Reported Outcomes teams to support companion diagnostic development and PRO activities
  • Work collaboratively Global Project Management and other functions to establish project development timelines; provide timely updates to the Development Sub-Team on any deviations from the plan
  • With the support of Medical Writing, author clinical trial protocols, amendments and related documents
  • Ensure that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on safety and medical monitoring
  • Develop and foster strong and effective working relationships with investigators and study sites; develop strong relationships with KOLs and other key investigators in oncology to optimize scientific quality and innovation of clinical study design, execution, reporting, and publication
  • Contribute to the development of clinical sections of regulatory documents such as investigator brochures, briefing books, safety updates, IND/BLA submission documents and responses to health authorities
  • Contribute to trial-related advisory boards; lead investigator meetings; lead protocol training meetings and support CPO's in the conduct of regional meetings
  • Collaborate with internal partners in interfacing with advocacy groups; represent and lead discussions of clinical activities and plans, and gather and respond to external feedback

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:


  • Work with internal partners on filing activities for Halozyme's lead asset, PEGPH20, as required
  • Serve as the external clinical "face" of the program in interactions with development partners
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:


  • Minimum of an MD degree with at least 2 years of clinical development experience in oncology within a biotechnology or pharmaceutical company (an equivalent combination of experience and education may be considered)
  • Experience in pediatric oncology preferred
  • Broad understanding of oncology, internal medicine and clinical pharmacology
  • Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development
  • Strong knowledge/expertise in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports)
  • Strong communication and collaboration skills
  • Oncology sub-specialty board certification preferred
  • BLA/NDA filing experience strongly preferred

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A

Software Knowledge: Windows, MS Office (Outlook, Power Point, Word, Excel), accessing and using an ERT database. Knowledge of other software required: Accessing and working with an electronic capture database

INTERNAL AND EXTERNAL RELATIONSHIPS:


  • PEGPH20 Development Subteam, Non-Clinical Research, Clinical Operations, Regulatory Affairs, Biostatistics, Translational Medicine and CMC
  • External interactions with site investigators, KOLs and regulatory authorities


Valid Through: 2019-10-2