Sr. Director, Clinical Operations
Company: Nektar Therapeutics
Location: San Francisco
Posted on: October 19, 2019
Sr. Director, Clinical Operations
Position OverviewThe Sr. Director, Clinical Operations will oversee
all aspects of the clinical operations for identified
This includes strategic and operational leadership relative to the
direction, planning, execution, and interpretation of clinical
programs and the data collection activities. Establishes and
approves (with CRO, Program Executive or Clinical Managers)
scientific methods for design and implementation of clinical
protocols, data collection systems and final reports. May also have
responsibility for partnered programs in the areas of supply
training, labeling, package design & pulmonary drug development.
Overall responsibility for adherence to protocols. Interacts with
various inside/outside groups to facilitate clinical programs. May
select, develop, and evaluate personnel to ensure the efficient
operation of the function. This job contributes to and supports the
company's research and development efforts to create high value
therapeutics to address unmet medical needs.
Consistently works on abstract problems across functional areas of
the business. Identifies and evaluates fundamental issues,
providing strategy and direction for major functional areas.
Interacts internally and externally with executive level management
requiring negotiation of extremely difficult matters to influence
policymaking bodies. Oversees the development and management of
Clinical Development Plans (CDP) which includes timelines, budget,
and resource requirements. Ensures the development and
implementation of clinical program strategy and directs those
systems and programs in order to meet Company goals and objectives.
Coordinates and directs outsourcing activities across program(s).
Creates and directs program advisory committees as needed, such as
Program Advisory Committee, DSMB and/or expert consultants.
Identifies program/resource gaps; devises and implements solutions.
Provides weekly enrollment and program updates to Senior
Management. Drives project risk analysis and develops solutions to
a variety of complex problems. Ensures that Clinical Operations
department effectively interfaces with key functional groups.
Remains current with medical developments and publications on
similar and competitor products. Applies this knowledge to current
programs. Mentors and develops Clinical Operations staff. Directs
internal staffing and performance management, including hiring,
training, coaching and performance reviews.
A Bachelors/Masters degree in a scientific discipline is required.
A PhD in a scientific discipline is preferred. Equivalent
experience may be accepted. A minimum of 15 years Pharmaceutical
development experience moving product candidates from Phase I
through pivotal, with at least 8 years managing CROs is required. A
minimum of 12 years previous management experience may be required.
Must have a demonstrated ability to solve problems with innovative
solutions along with strong organizational skills. Excellent
written and verbal communication skills are required. Previous
experience working with senior management is required. Experience
and understanding of ICH, and GCP is required. Knowledge of GMP and
GLP is preferred. Must be a demonstrated self-starter and team
player with strong interpersonal skills. Must possess excellent
project management skills. Must have strong computer skills with a
proficiency in Microsoft Project, Word, Excel, Visio, and
We are an Equal Opportunity Employer and do not discriminate
against applicants due to race, ethnicity, gender, veteran status,
or on the basis of disability or any other federal, state or local
protected class. Nektar Therapeutics will consider for employment
qualified applicants with criminal histories in the manner
proscribed by the San Francisco Fair Chance Ordinance.
Keywords: Nektar Therapeutics, San Bruno , Sr. Director, Clinical Operations, Executive , San Francisco, California
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