Medical Director (Oncology)
Company: dMed / Clinipace Inc.
Location: Morrisville
Posted on: May 25, 2023
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Job Description:
Job Title: Medical Director Job Location: United States, Remote
Job Overview: Primary responsibilities include medical and safety
oversight of clinical trials as well as corporate support for
business opportunities. The Medical Director provides Medical
Monitoring services to clinical trials with the aim to monitor the
safety and wellbeing of study participants, integrity of the
project data in accordance with the clinical trial
protocol/clinical study protocol (or equivalent documents),
standard operating procedures (SOPs), good clinical practice (GCP),
and all other applicable directives and regulatory requirements.
Job Duties and Responsibilities: Medical Monitoring: Provides
Medical oversight of projects to ensure GCP/national and
international regulatory requirements, Policies/SOPs/WPs, and
Sponsor directives are followed. Provides Medical consultation to
Sponsors and project teams for protocol development and/or project
activities, as indicated. Maintains availability to the sites and
project team including the Sponsor to ensure that medical questions
or medical aspects of project-related questions (e.g. safety,
general protocol questions, subject eligibility,
inclusion/exclusion criteria, screening, randomization, unblinding,
dosing, termination and discontinuation, IP-specific questions,
etc.) are answered or communicated for resolution. Develops/updates
the Medical Monitoring Plan (MMP), circulating it for approval
within the company and with Sponsor Reviews project specific plans,
including the Safety Management Plan (SMP). Reviews and advises on
project-related documents (e.g. study protocol, Informed Consent
Form, clinical study report, etc.), as indicated. Develops and/or
reviews project-related documents and reports, assesses and
interprets project results. Reviews medical literature in the scope
of preparation of project-related documents and provides input for
preparation of the respective documents. Reviews and assesses
issues related to protocol compliance, including protocol
deviations/violations, development of the corrective and
preventative actions. Trains CRAs and other team members on
different topics, including medical and/or safety aspects of the
project or therapeutic area/indication. Attends internal and
external project meetings Reviews laboratory results and lab/ECG
alerts, as required. Provides Medical review and assessment of
SAEs, adverse events of special interest, SAE narratives, expedited
and periodic safety reports, as requested. May write medical
sections of periodic safety reports (e.g., risk-benefit
assessments) and/or review safety data for trends. Provides Medical
review of study data, as per the MMP/Medical data review plan, for
clarifying and resolving data inconsistencies, query management,
trend assessment, etc. May review requests from Regulatory
Authorities and/or Ethic Committees/IRBs and related activities
with preparation of responses, when requested. Escalates issues and
notifies Line Manager, Project Manager, and/or other responsible
staff if urgent safety issues are identified. Works closely with
other functional groups and departments including but not limited
to Safety/Pharmacovigilance, Project Management, Clinical
Operations, Data Management, Biostatistics and QA to ensure that
medical operational functions are executed effectively as per
contract. Business Development Support (as needed): Supports
Business Development by preparing protocol considerations for new
Proposals, answering Requests for Information, etc. Participate in
capability and bid defense meetings, as needed, to provide medical
and scientific advice for potential new projects May work with
Feasibility to identify potential sites for a project; review
feasibility questionnaires; and/or discuss capabilities by e-mail
or phone. Supervisory Responsibilities: Will not have direct
reports but will be responsible for mentoring and assisting in the
training of others. Job Requirements: Education MD (or
country-specific equivalent) required, postgraduate
training/eligibility for licensure preferred. Experience Minimum of
3 years of direct oncology experience At least 5 years of
experience research experience post-training. CRO experience is
preferred Prior experience across the spectrum of Medical
Monitoring activities, including Medical review of safety
information Prior experience in development and delivery of
therapeutic area/protocol-specific trainings and presentations
Experience representing the company in meetings with
pharmaceutical/biotechnology companies is preferred
Skills/Competencies Deep understanding of the scientific basis for
therapies and drug-induced diseases Comprehensive knowledge of
medical device, vaccines and drug development process High level
understanding of pharmacovigilance processes Extensive knowledge of
GCP/applicable regulations and guidance''s, including but not
limited to national/regional regulations as well as ICH Guidance
Comfortable communicating both internally and externally, including
delivering presentations Maintain a calm and positive winning
attitude, and excellent decision-making skills Assist in team''s
success through establishing and clear articulation of goals
Ability to train and mentor others Able to prioritize action items
and maintain a good sense of urgency Capabilities Proficient in the
use of computers and Microsoft Office applications Ability to
travel occasionally, in support of business needs LI-BG1
LI-RemoteThe company will not accept unsolicited resumes from third
party vendors.
Keywords: dMed / Clinipace Inc., Cary , Medical Director (Oncology), Executive , Morrisville, North Carolina
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