Senior Director, Clinical Operations - Therapeutics
Company: Moderna Therapeutics
Location: Cambridge
Posted on: May 22, 2023
Job Description:
Senior Director, Clinical Operations - Therapeutics page is
loaded Senior Director, Clinical Operations - Therapeutics Apply
locations Cambridge, Massachusetts Clinical Development time type
Full time posted on Posted 4 Days Ago job requisition id R12748 The
Role:Moderna is seeking a Senior Director, Clinical Operations to
manage therapeutics programs across the Therapeutics portfolio with
a focus on Rare Diseases. The Senior Director, Clinical Operations,
Therapeutics will function as a portfolio lead with oversight of
programs and the clinical operations team(s) on those programs.
This position will work collaboratively across the therapeutics
portfolio and cross-functional teams on the overall development
programs and related studies to ensure successful execution of
assigned projects. This position will be responsible for initiating
and leading clinical programs across all phases, including
overseeing CROs and vendors and working cross-functionally on
clinical operations strategy and related initiatives. Additionally,
this position will be responsible for management of clinical
operations staff which includes but is not limited to talent
management, hiring, management and organization of clinical
operations teams assigned to programs and studies. This position
reports to the Executive Director, Clinical Operations.Here's What
You'll Do:
- Serve as a Clinical Operations Portfolio Lead across the
Therapeutics, overseeing several programs and the clinical
operations team(s) assigned to those programs. These programs may
span therapeutic areas such as rare disease, autoimmune,
cardiovascular, and other emerging disease areas within
Therapeutics. This position will focus on rare disease.
- Accountable for delivery of programs and studies within the
assigned portfolio.
- Oversee clinical operations teams and provide direction,
oversight and mentorship to ensure the development of operational
strategy and plans in support of execution of the Clinical
Development Plan.
- Partner and collaborate with cross-functional stakeholders as
well as senior leaders at the therapeutic and functional line head
level (eg. VP of clinical development, function line heads) to
ensure clinical operations effectiveness.
- Oversee execution of first-in-human through phase 4 trials,
depending on lifecycle of program, in compliance with ICH/GCP,
local regulations, and Moderna SOPs. May serve as the program
clinical operations lead (PCOL) for programs in early development
until assignment of additional clinical operations resources.
- Manage and provide oversight to the cross functional team and
CRO/vendor(s) related to all aspects of clinical trial
operations.
- Responsible for budget management for assigned
programs/portfolio including ensuring proactive management of all
finance activities including but not limited to periodic budget
reviews, CRO budget oversight and internal processes related to
forecasting at the program and study level.
- Responsible for representing Clinical Operations as a senior
leader on cross-functional project teams and vendor/CRO operational
meetings and ensuring compliance with operational standards and
procedures.
- Support and supervise the selection, oversight, and management
of CROs and other vendors.
- Perform and document study level Sponsor Oversight of
outsourced clinical activities as assigned/applicable.
- Oversee program/study team conduct of site
feasibility/capability assessments in collaboration with the CRO
and cross-functional team.
- Review and provide clinical operations input into relevant
clinical documents such as the protocol, investigator brochure,
regulatory documents, clinical study reports and other documents
and plans as appropriate.
- Along with other Clinical Development personnel, represent
Moderna externally to Investigators, site staff, and Key Opinion
Leaders.
- Communicate and present to senior leaders on issues, strategies
to align, manage and solve issues that arise within the assigned
portfolio (program, timelines, budget, other issues as
applicable).
- Oversee/collaborate on and contribute to inspection readiness
activities that support audits and regulatory inspections related
to clinical trial conduct.
- Maintain oversight and participate in the
creation/review/training/maintenance of departmental and
organizational SOPs to ensure compliance.
- Lead and/or participate in clinical operations workstreams
related to departmental and operating model related
initiatives.
- Develop and foster strong, collaborative relationships with key
stakeholders both within and external to Moderna.
- Manage clinical operations staff across program and study roles
which includes but is not limited to talent management, hiring,
management and organization of clinical operations teams assigned
to programs and studies.
- Strive for continuous improvement and more efficient ways of
working in clinical development.
- Act as a role model for Moderna's values.Here's What You'll
Bring to the Table:
- Minimum of BA/BS with at least 12 years of trial and clinical
program experience, including 8+ years of high complexity
independent, global trial management experience and 4+ years of
program-level management Advanced degree preferred.
- Experience in complex disease areas (e.g., rare disease,
autoimmune, cardiovascular and oncology). Rare disease experience
required.
- Robust experience in early and late phase drug development
- Multi-dimensional Clinical Operations background with
capability of devising plans for operational challenges such as
site activation, subject enrollment, monitoring oversight, protocol
deviation management, data cleaning, etc.
- Cross-Collaboration proficiency with other therapeutic areas
and functions such as Regulatory, CMC, Biostatistics, Data
Management, Finance, Program Management, etc.
- Experience in GCP inspections/audits
- Outstanding verbal and written communication skills, in
addition to excellent organizational skills
- Proven track record of effective leadership and team-building
skills in the context of a multi-disciplinary team in the biotech
or pharmaceutical industry
- Resilient, Creative, capable problem-solver
- Excellent organizational skills and ability to work
independently
- Experience in establishing and maintaining relationships with
key opinion leaders
- Some travel requiredModerna is pleased to provide you and your
family with a comprehensive and innovative suite of benefits,
including:
- Highly competitive and inclusive medical, dental and vision
coverage options
- Flexible Spending Accounts for medical expenses and dependent
care expenses
- Lifestyle Spending Account funds to help you engage in personal
enrichment and self-care activities
- Family care benefits, including subsidized back-up care options
and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness
classes -
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+
community
- Generous paid time off, including:
--- Vacation, sick time and holidays
--- Volunteer time to participate within your community
--- D iscretionary year-end shutdown
--- Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid
parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as
voluntary benefit options
- Complimentary concierge service including home services
research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras! Candidates should be aware
that Moderna currently maintains a policy requiring all US-based
employees to be fully vaccinated against COVID-19 and receive a
booster shot once eligible . Newly hired employees must be
vaccinated and boosted prior to their employment start date.
Moderna is an equal opportunity employer and will provide a
reasonable accommodation to those unable to be vaccinated or
receive a booster where it is not an undue hardship to the company
to do so as provided under federal, state, and local law. About
ModernaIn over 10 years since its inception, Moderna has
transformed from a research-stage company advancing programs in the
field of messenger RNA (mRNA), to an enterprise with a diverse
clinical portfolio of vaccines and therapeutics across seven
modalities, a broad intellectual property portfolio in areas
including mRNA and lipid nanoparticle formulation, and an
integrated manufacturing plant that allows for rapid clinical and
commercial production at scale. Moderna maintains alliances with a
broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
groundbreaking science and rapid scaling of manufacturing. Most
recently, Moderna's capabilities have come together to allow the
authorized use and approval of one of the earliest and most
effective vaccines against the COVID-19 pandemic.Moderna's mRNA
platform builds on continuous advances in basic and applied mRNA
science, delivery technology and manufacturing, and has allowed the
development of therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases and
autoimmune diseases. Moderna has been named a top biopharmaceutical
employer by Science for the past seven years. To learn more, visit
www.modernatx.com .Moderna is a smoke-free, alcohol-free and
drug-free work environment.Moderna is committed to equal employment
opportunity and non-discrimination for all employees and qualified
applicants without regard to a person's race, color, gender, age,
religion, national origin, ancestry, disability, veteran status,
genetic information, sexual orientation or any characteristic
protected under applicable law. Moderna will make reasonable
accommodations for qualified individuals with known disabilities,
in accordance with applicable law.#LI-TR2- Similar Jobs (1) Senior
Director, Clinical Operations - Oncology locations 2 Locations time
type Full time posted on Posted 4 Days Ago About Us Our Mission and
VisionAt Moderna we are pioneering the development of a new class
of drugs made of messenger RNA (mRNA). This novel drug platform
builds on the discovery that modified mRNA can direct the body's
cellular machinery to produce nearly any protein of interest, from
native proteins to antibodies and other entirely novel protein
constructs that can have therapeutic activity inside and outside of
cells.We have a clear mission to propel the field of mRNA science
forward and deliver new medicines to patients and a unique vision
for how to achieve this mission.Our Mission: To deliver on the
promise of transformative messenger RNA (mRNA) science to bring new
medicines to patients.Our Vision: To unlock the potential of mRNA
by establishing an ecosystem of teams and partners that will work
together to develop the broadest possible array of drugs, across
diverse therapeutic areas and routes of administration, for serious
diseases that are not treatable today.Third Party Staffing
AgenciesM oderna does not accept unsolicited resumes from any
source other than directly from candidates. For the protection of
all parties involved in the recruiting process, resumes will only
be accepted from recruiters/agencies if a signed agreement is in
place at the inception of the recruiting effort and authorized for
a specified position. Unsolicited resumes sent to Moderna from
recruiters/agencies do not constitute any type of relationship
between the recruiter/agency and Moderna and do not obligate
Moderna to pay fees if we hire from those resumes. Reasonable
Accommodation NoticeModerna will make reasonable accommodations for
qualified individuals with known disabilities, in accordance with
applicable law.Applicants with disabilities may be entitled to
reasonable accommodation under the terms of the Americans with
Disabilities Act and certain state or local laws. Please inform the
company's personnel representative by calling 617-460-9346 or
emailing humanresources@modernatx.com if you need assistance
completing any forms or to otherwise participate in the application
process.Examples of reasonable accommodation include making a
change to the application process or work procedures, providing
documents in an alternate format, using a sign language
interpreter, or using specialized equipment.Return Home
Keywords: Moderna Therapeutics, Cambridge , Senior Director, Clinical Operations - Therapeutics, Executive , Cambridge, Massachusetts
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