Director, Clinical Development, Oncology - Hematology and Transplant (
Company: Necnic Group, LLC
Location: Palo Alto
Posted on: August 2, 2020
Hematology/Oncology opening in Palo Alto, California. Director,
Clinical Development, Oncology - Hematology and Transplant
Opportunity to join an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. We are continuing to expand our commercial product portfolio
and our research and development pipeline in therapeutic areas that
can leverage our unique expertise.
The therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.
In collaboration with the clinical teams, the primary role is to
lead and execute early/late stage clinical trials for oncology
products in the hematology/stem cell transplantation space in
development. Participates in the design/planning of clinical
studies and helps with the interpretation of study results.
Establishes and approves scientific methods for design and
implementation of clinical protocols, data collection systems and
final reports. May recruit clinical investigators for research
studies. Responsibilities also include adverse event
monitoring/safety signal assessments and clinical trial safety
responsibilities. Coordinates and develops reporting information
for reports submitted to the FDA. Participates in investigator
training, site training, advisory board preparation, protocol
generation, clinical study report generation, etc. Monitors
adherence to protocols and oversees study completion.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
--- Support the establishment of clinical trial strategies for
oncology products in development.
--- 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
--- Collaborate with internal safety group in analyzing and
reporting of safety data from clinical trials.
--- Analyze and interpret other clinical trial data and prepare
reports for regulatory agencies and publication.
--- Interact with key opinion leaders and investigators in relevant
disease specific area.
--- Ensure consistency of scientific and development strategies for
oncology products in development.
--- Maintain the highest level of scientific and clinical /clinical
trial outcomes knowledge in relevant disease specific area.
--- May supervise employees, both directly and indirectly through a
dotted line structure; responsibility working with Clinical
Research Organizations and other internal support groups.
--- MD with board certification or eligibility in Oncology or
Hematology/Oncology, or related specialty.
--- Five to seven years of drug development experience in
biotechnology or pharmaceutical industry, or a combination of
academia and industry. Note: Individuals with extensive academic
experience including clinical trial work but without experience in
the pharmaceutical industry may be considered.
--- Hands-on experience in the design, execution, and reporting of
early stage and 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).
--- Proven ability to effectively work in a cross-functional/matrix
--- 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
--- Identifies and implements methods, techniques, procedures and
evaluation criteria to achieve results.
--- Leads or manages the work of others by providing guidance to
subordinates based on organizational goals and company policy, with
responsibility for results, including costs, methods and
--- 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
--- Works on complex problems where analysis of situations or data
requires an in-depth evaluation of various factors
--- Works on abstract problems across functional areas of the
--- Exercises independent judgment in methods, techniques and
evaluation of criteria for obtaining results.
--- May ensures budgets and schedules meet corporate
--- Creates formal networks involving coordination among groups.
Regularly interacts with executives and/or major customers.
Keywords: Necnic Group, LLC, Palo Alto , Director, Clinical Development, Oncology - Hematology and Transplant (, Healthcare , Palo Alto, California
Didn't find what you're looking for? Search again!