Associate Director, Clinical Operations, Oncology
Company: Moderna Therapeutics
Location: Cambridge
Posted on: April 8, 2021
Job Description:
Associate Director, Clinical Operations, Oncology Cambridge,
Massachusetts 200 Technology Square - Cambridge - USA - MA The
Role:Moderna is seeking an Associate Director of Clinical
Operations to manage programs within the Oncology Therapeutic Area,
which may consist of managing one or more studies. This position
will be responsible for initiating and leading clinical trials
across all phases, including overseeing CROs and vendors and
working cross-functionally on clinical operations strategy and
related initiatives. This position reports to the Senior Director,
Clinical Operations. This position will work collaboratively across
the therapeutic area and cross-functional teams on the overall
development programs and related studies to ensure successful
execution of assigned projects.Here's What You'll Do:
- Accountable for delivery of assigned clinical program/studies
budget, timelines, and resource management with focus on quality,
including making recommendations and decisions regarding
operational strategies to support study and/or program
objectives
- Develop operational strategy and clinical operations plans in
support of execution of the Clinical Development Plan
- Partner and collaborate with cross-functional stakeholders such
as the Project Leader, Clinical Lead and other relevant
stakeholders
- Lead and 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
- Manage invoice and budget tracking for individual studies and
provide input into budget forecasting activities
- Support the selection, oversight, and management of CROs and
other vendors
- Oversee 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
- Manage the cross functional team and CRO/vendor(s) related to
all aspects of clinical trial operations
- Responsible for representing Clinical Operations on
cross-functional project teams and vendor/CRO operational meetings
and ensuring compliance with operational standards and
procedures
- Along with other Clinical Development personnel, represent
Moderna externally to Investigators, site staff, and Key Opinion
Leaders
- Perform and document study level Sponsor Oversight of
outsourced clinical activities
- Communicate study-status, cost and issues to ensure timely
decision-making by senior management
- Manage invoice and budget tracking for individual studies and
provide input into monthly and annual forecasting activities for
studies and programs
- 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
- Support program level deliverables/activities at the discretion
of the Senior Director, Clinical Operations
- Provide oversight and mentorship to assigned Clinical Trial
Managers and Clinical Trial Associates by providing clinical
operations and functional area expertise
- Strive for continuous improvement and more efficient ways of
working in clinical development
- Act as a role model for Moderna's valuesHere's What You'll
Bring to the Table:
- Minimum of BA/BS with at least 8-10 years of trial and clinical
program experience, including at least 4 years of independent
clinical trial management experience and full trial life cycle
experience (e.g., start-up, conduct, closure). Advanced degree
preferred.
- Robust experience in immuno-oncology required. Experience in
hematologic malignancies desirable but not required.
- Robust experience in early and late phase global 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 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 requiredHere's What We'll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail
pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical
offered through BCBS (HMO/PPO), dental, and vision offered through
VSP
- Flexible Spending Accounts for medical expenses and dependent
care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Eligible for "Moderna Month" (one month paid sabbatical after
five years of service and eligible for additional one month paid
sabbatical every 3 years thereafter)
- Adoption assistance and discounts to local childcare centers,
as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6%
deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life
insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a
discretionary winter shut down and 11 company paid holidays
(includes 2 floating holidays) About Moderna: In 10 years since its
inception, Moderna has transformed from a science research-stage
company advancing programs in the promising-but-still-unproven
field of messenger RNA (mRNA), to an enterprise with its first
medicine having treated millions of people, a diverse clinical
portfolio of vaccines and therapeutics across six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. 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 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 auto-immune diseases.
Today, 24 development programs are underway across these
therapeutic areas, with 13 programs having entered the clinic.
Moderna has been named a top biopharmaceutical employer by Science
for the past six 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-JM1- Posted 30+ Days Ago Full time R3623
About Us Our Mission and Vision At 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 Agencies M 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 Notice Moderna 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.
Keywords: Moderna Therapeutics, Cambridge , Associate Director, Clinical Operations, Oncology, Executive , Cambridge, Massachusetts
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