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Sr. Manager/Director, Clinical Development

Status: Archived
Companyzentalis
LocationSemi Remote, New York
Expiration2021-09-14
How to Apply

https://zentalis.bamboohr.com/jobs/view.php?id=71

Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.

 

SUMMARY

We are looking for an individual at a level between Senior Manager and Director/Senior Director to enrich our clinical development team, including candidates with PharmD and PhD background who are interested in hands-on Clinical Research and Development. The individual will contribute to the development and oversee the execution of oncology clinical research studies, ensuring consistency and quality, across the assigned development program. Together with the VP, Clinical Development and in collaboration with the Zentalis clinical research team and clinical operations teams the primary role is to participate in (Senior Manager) or lead and execute (Director level) early/late-stage clinical trials for oncology products in development. This individual will participate in the design/planning of clinical studies, help with the interpretation of study results and establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. The individual may recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities including adherence to protocols and determining study completion.

 

RESPONSIBILITIES

  • Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
  • Act as medical monitor for company sponsored trials.
  • Support project teams with therapeutic area specific information.
  • Work closely with functional partners (Data Management, Biostatistics, Regulatory, Clinical Operations, Quality) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in clinical development and in close collaboration with other key functional stakeholders.
  • Collaborate with safety group in analyzing and reporting of safety data from clinical trials.
  • Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication.
  • Ensure consistency of scientific and development strategies for oncology products in development.
  • Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.
  • Participate in strategic study start-up planning in collaboration with other functions including early site assessment and feasibility to accelerate rate of site activations.
  • Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents.
  • Work closely with Medical Writing to support protocol or protocol amendment completion.
  • Work closely with VP Clinical Development, Clinical Research, Regulatory and Clinical Operations to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.
  • Work closely with Clinical Operations to track study recruitment and implement action plans to address early impediments to study enrollment.
  • Work closely with Quality to review potential audit findings and implement effective corrective action plans.
  • Work closely with VP Clinical Development, Clinical Research and Data Management to support medical review and data query resolution.
  • Interact with clinical investigators and Key Opinion Leaders as appropriate.
  • Work with Clinical Operations to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct.
  • Work with the VP Clinical Development, Data Management and with Statistics on analysis of study results and completion of study reports.
  • Work with the VP Clinical Development to support the development and compilation of potential future NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing.
  • May review/co-author medical publications emerging from clinical trial results.
  • May act as a liaison between company and clinical investigators, vendor managers, and CROs.
  • May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards.

 

QUALIFICATIONS

  • PharmD, PhD or MD, the latter preferably with board certification or eligibility in Oncology or Hematology/Oncology.
  • Three years or more of development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with relevant extensive academic experience but without experience in the pharmaceutical industry may be considered.
  • Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
  • Participated in clinical oncology studies with molecular targeted or immunological therapies.
  • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
  • Effective leadership, people management, communication skills and a team-oriented style are essential.
  • Must be willing and able to be hands-on and to effectively work in a cross-functional/matrix environment.
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
  • Develops technical and/or business solutions to complex problems.
  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
  • Ability to develop and maintain relationships with significant key opinion leaders.
  • Strong interpersonal, influencing, presentation, and written and verbal communication skills
  • Strong organizational and time management skills
  • Ability and strong desire to “make things happen”. Must have a results-oriented work ethic and a positive, can-do attitude.
  • Flexible, creative, and resourceful style and attitude is required. Must be open to change and the unknown with ability to shift gears quickly.
  • Trustworthy with highest integrity; committed to ethics and scientific standards
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