Senior Manager, Strategic Outsourcing
Company: FibroGen, Inc
Location: San Francisco
Posted on: March 19, 2023
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Job Description:
Senior Manager, Strategic Outsourcing page is loaded Senior
Manager, Strategic Outsourcing Apply locations San Francisco, CA
time type Full time posted on Posted Yesterday job requisition id
2023390 Senior Manager, Strategic Outsourcing
This person will be a member of the Strategic Outsourcing Team. The
Senior Manager will assist in the qualification and selection of
clinical vendors, support contracting activities, support
negotiations, and manage site budgets and compensation with
clinical sites. This includes both sites managed directly by
FibroGen or by a CRO.
This position will manage the process and workflow of site
contracts, ensure compliance with existing agreements, and ensure
the proper routing of documents for execution by corporate officers
and perform other duties as assigned. The Senior Manager will
draft, negotiate and execute vendor contracts throughout the
duration of the clinical studies. This person must have the ability
to properly vet vendors prior to introducing them to the team and
be able to negotiate while not comprising the safety and integrity
of the scope of work to be performed.
Specific duties:
--- Work cross functionally with clinical development teams
(clinical, DM, Biometrics, safety, regulatory, quality and legal)
to define and review vendor contract proposals and budgets
--- Develop RFPs in support of the clinical development run by
FibroGen
--- Draft and finalize clinical work orders, change orders, service
agreements and consulting agreements according to the defined scope
of work
--- Participate in weekly/biweekly study team meetings and CRO
teleconferences to track study progress/protocol amendments and
manage vendor compliance with the scope of work as well as monitor
contracts for compliance with company and department policies
--- Work with the business operations team to strategically review
and compare study budgets and provide the feedback directly to the
vendor and/or to the clinical review team members
--- Facilitate vendor qualification and vendor selection by leading
capability presentations, bid defenses, internal team discussions
and score card reviews for both large and small studies; maintain
vendor selection documentation
--- Negotiate with the vendors regarding RFPs, proposal comments
and detailing deliverables to be included in the final scope of
work
--- Submit financial and contractual approval requests being able
to address questions/comments regarding the contract up for
approval
--- Pro-active in identifying issues internally with vendors that
could interfere with achievement of project goals and timelines and
resolve disputes in a timely manner
--- Initiate, cultivate and maintain strong relationships with
vendors and the study teams they support
--- Manage the status of clinical trial budgets coordinating with
legal for both sites and vendors.
--- Review the budgets that have been negotiated by the team
members and ensure that they are accurate and compliant with
FibroGen policies and best practices.
--- Format and finalize site CTAs for execution
Experience/Requirements:
--- Minimum BA/BS degree or relevant graduate degree highly
preferred
--- Minimum of four to six (4-6) years of experience in a contract
and/or business operations environment in a pharmaceutical, CRO/
biotech company or worked in a clinical operations setting with a
CRO/Sponsor company
--- Expertise in clinical trials is required.
--- Direct experience vetting and negotiating with vendors is a
must.
--- Ability to understand the clinical development process and
demonstrate the capability of managing multiple external vendors
for multiple clinical trials simultaneously
--- Demonstrated leadership qualities, including the ability to say
"no."
--- Knowledge of applicable regulatory and ICH guidance regarding
clinical research and GCP.
--- Demonstrated ability to independently solve problems in a
rapidly changing environment.
--- An excellent communicator, both written and verbal, with the
ability to train and present data as required.
--- Excellent organizational skills and attention to detail.
--- An innovative, driven and effective person with a "can do"
attitude.
--- A goal-oriented person who can plan for the long-term and
execute stated objectives.
--- Proficiency with MS Word, Excel, Access and Outlook required
SALARY RANGE $180,500.00-$195,100.00 FibroGen is an equal
opportunity employer and prohibits unlawful discrimination based on
race, color, religion, gender identity/expression, creed, national
origin/ancestry, age, alienage or citizenship, status, age, sex,
sexual orientation, marital or domestic/civil partnership status,
disability, veteran status, genetic information, or any other basis
protected by law. FibroGen will consider for employment qualified
applicants with criminal histories in a manner consistent with the
requirements of the San Francisco Fair Chance Ordinance. At
FibroGen we continue to strive to build a diverse and equitable
workplace; we share the typical minimum and maximum salary ranges
on all job postings. For annual base pay, we typically set standard
ranges for positions based on function and level benchmarks.
Further, we establish fixed annual bonus targets, expressed at a %
of annual base pay, based on level in the organization. Bonus
awards are determined based on assessment of individual and
corporate goal achievement. All compensation offers of employment
are determined by multiple factors including a candidate's relevant
qualifications, work experience, skills, and other factors and may
vary from the amounts listed above. Notice to Recruiters and Search
Firms FibroGen does not accept unsolicited resumes or
communications. Contact with a hiring manager or submission or
presentation of candidates by recruiters or placement agencies
without a current signed agreement with FibroGen will not
constitute, in any form, a financial obligation or agreement for
recruitment services or placement support or consulting
fees.E-Verify: Notice to all Prospective Employees Similar Jobs (1)
Senior Director, Strategic Outsourcing locations San Francisco, CA
time type Full time posted on Posted 19 Days Ago About Us FibroGen,
Inc. is a leading science-based biopharmaceutical company
discovering and developing a pipeline of first-in-class
therapeutics. The company applies its pioneering expertise in
fibrosis and hypoxia-inducible factor (HIF) biology and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Please visitwww.fibrogen.com
to learn more about FibroGen where we believe that our employees
are our most important asset and dedicated to remaining a great
place to work. -
Keywords: FibroGen, Inc, San Francisco , Senior Manager, Strategic Outsourcing, Executive , San Francisco, California
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