Associate Director, Clinical Operations
Company: Escient Pharmaceuticals, Inc.
Location: San Diego
Posted on: January 25, 2023
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Job Description:
Escient Pharmaceuticals is a San Diego based a clinical-stage
company focused on developing novel therapeutics to address a broad
range of neurosensory-inflammatory disorders. The company's
pipeline includes two first-in-class small molecule antagonists
targeting MRGPRX2 for the treatment of various mast cell mediated
disorders and MRGPRX4 for cholestatic pruritus. Escient is led by
an experienced management and scientific team and funded by
top-tier life science investors. Our team is driven by the desire
to make a positive difference in the lives of patients. We are
passionate about innovative science and strive to discover and
develop novel medicines, to bring value to the healthcare
ecosystem, and to address significant unmet medical needs. We
foster a culture of innovation, collaboration, transparency, mutual
respect, and integrity and an environment where employees feel
fulfilled by the work they do and are recognized for the
contributions they make. Escient is seeking a dynamic, creative and
highly motivated individual for the position of Associate Director,
Clinical Operations who will be responsible for running the
day-to-day management and oversight of the clinical study team to
ensure successful clinical trial implementation and execution. The
clinical study team is comprised of internal and external matrixed
functions including CROs and other vendors and
employees/consultants representing functions including but not
limited to clinical operations, biostatistics and programming, data
management, clinical safety, clinical science, clinical
pharmacology/bioanalytical and regulatory. The ideal candidate is
forward thinking and creative with high ethical standards, a team
player with strong leadership skills who is able to work in a
fast-paced environment with drug development professionals and able
to respond to changing priorities in a thoughtful, creative manner
MAIN RESPONSIBILITIES include the following: Accountable for the
day-to-day management and oversight of the clinical study team to
ensure successful clinical trial implementation and execution. The
clinical study team is comprised of internal and external matrixed
functions, including CROs and other vendors and
employees/consultants representing functions including but not
limited to clinical operations, biostatistics and programming, data
management, clinical safety, clinical science, clinical
pharmacology/bioanalytical and regulatory. Develop and implement
(with management and team support) the operational plans including
effective selection of CROs and other vendors, negotiation of
site/vendor terms, establishment of smooth project integration and
ensuring timely and compliant implementation. Actively and
effectively communicate within Clinical Development, progress,
activities and results for assigned responsibilities. Escalate and
resolve vendor issues as necessary. Communicate challenges along
with risk mitigation options and/or solutions. Prepare and deliver
status updates as needed. Forecast trial resource needs (external
costs). Accountable for managing/tracking study budgets. Evaluate
novel methods of implementation that may lead to accelerated and/or
higher quality clinical trial implementation. Provide input into
(and in some cases prepare) all clinical trial plans and documents
(protocol, informed consent, study manuals, monitoring plans, data
management plans, safety management plans, etc.). Ensure all
clinical activities are delivered in accordance with expectations,
trial protocol, ICH/GCP guidelines and applicable SOPs and
regulations EDUCATION AND QUALIFICATIONS Bachelor's degree and 10
or more years' experience in Clinical Operations roles with a
minimum of two years as a manager or above with direct involvement
in early phase human clinical trials Proven ability to effectively
lead cross functional clinical project teams Prior experience with
managing complex clinical studies with a keen understanding of all
phases of clinical operations, including clinical trial design,
study implementation/start-up activities, clinical research
associates and site management, data management, and study close
out. Direct involvement in early phase clinical trials and/or
clinical trials ex-US is preferred. In-depth experience managing
small and large CROs with a track record of successful completion
of outsourced studies including time to completion and remaining
within budget. Experience with evaluating CRO and vendor proposals,
negotiating key terms (including budgets) and selecting/initiating
these relationships Experience interacting with and building strong
relationships with clinical sites Experience in review or writing
of clinical protocols, study manuals, case report forms, and
informed consent forms Ability to present technical and business
aspects of projects Strong interpersonal skills with an ability to
effectively communicate to people at all levels of an organization
Demonstrated problem solving skills, a strong sense of urgency,
keen attention to detail, and the ability to plan, organize and
successfully execute in an environment under time and resource
pressures. Must be focused and able to meet tight timelines.
Current knowledge of GCP, ICH guidelines and FDA regulations as
well as familiarity with EMA/CHMP regulations and guidelines, and
other international regulatory requirements. This is a hybrid
remote position, and candidates must be able to report to the San
Diego office periodically. Travel will be required to the extent
necessary for oversight of vendors and clinical sites (anticipated
5 - 10%). Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee will
regularly be required to use his/her hands and fingers to operate a
computer keyboard, mouse, and telephone keypad or to write, as well
as talk and hear. The employee will regularly be required to sit,
stand, walk, talk and hear; use hands to handle or feel; see
computer screens and read printouts; and reach with arms and hands.
Specific vision abilities required by this job include close
vision, distance vision, peripheral vision, depth perception and
ability to focus. If you thrive in a fast-paced, entrepreneurial
environment and are in search of a dynamic, multi-disciplinary team
focused on discovering and developing therapies that will
positively change the course of the health and well-being of
underserved patients, we encourage you to apply. Escient
Pharmaceuticals offers a positive and exciting work environment
with competitive pay structures and benefits. Escient is an equal
opportunity employer.
Keywords: Escient Pharmaceuticals, Inc., San Diego , Associate Director, Clinical Operations, Executive , San Diego, California
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