Site Head, Global Safety, Oncology - San Francisco Area
Company: TANNER & ASSOC INC
Location: San Francisco
Posted on: April 21, 2024
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Job Description:
Site Head, Global Safety, Oncology - San Francisco Area Site
Head, Global Safety, Oncology - San Francisco Area Job Description:
To lead the oncology therapeutic area by providing strategic safety
leadership and expertise, continuous development and mentoring of
TA staff, logistic and other staff planning activities as
warranted. Will serves as the TA safety core member on select
goverance governance committees; and ensures the efficient
functioning of the Global Safety Teamsglobal safety framework. The
Global Safety Executive Medical Director TAH will lead by
supervising and managing the direction of the oncology portfolio:,
including providing high level safety strategy, personnel and
resource management, mentoring of staff, and providing
cross-functional safety leadership at key governance meetings.
Responsibilities: ---Accountable for review and approval of all
regulatory responses or strategic GST deliverables including but
not exclusive to RMPs, PSURs, PSAPs, GSSP, SARs
--- Represent TA in meetings with Management/governance boards,
regulatory agencies and external partners
--- Provide timely safety input to GRAAS Leadership, senior
management review committees, and governance boards as needed.
--- Provide functional expertise to guide the development of new
department and cross-functional processes
--- Advise and approve Individual Development Plans and Goals for
TA staff members
--- Work cross-functionally with Regulatory TA Heads to reach GST
issue resolution on safety related issues.
--- Monitor TA staff compliance with assigned SOP and compliance
training
--- Lead significant cross-functional projects or initiatives
Skills: --- Extensive knowledge of drug development (Non clinical,
clinical and CMC aspects), global pharmacovigilance principles,
commercialization, and safety escalation governance processes,
global regulatory authority operations, global regulatory agency
submission process, technical skills (such as Microsoft Outlook,
Word, Excel, Power Point); ;and working globally.
--- Visionary strategic leadership abilities (Charts the course).
Proven track record as an effective team and strategic leader in a
Matrix environment (as well as working with a subsidiary company of
a larger organization). Issue and conflict management skills
required. Strong interpersonal skills needed to navigate cross
functionally between 2 companies and outstanding communication
skills including oral and written (medical writing) required.Also
must possess strong negotiation, critical thinking and problem
solving skills.
Competencies
Knowledge:
Accountable for budget and administration for sizeable operations
for a sub-function OR Accountable for budget and operations for a
medium-sized site. Collaborates with sub-functional leadership to
set strategy and business objectives. Problem Solving:
Establishes operational objectives for managers and/or teams of
professionals across the sub-function - Guided by functional
strategy. Provides authoritative advice to top management based on
deep subject matter expertise.Autonomy:
Leads a team of other global safety officers and safety scientists
who are accountable and responsible for the global safety of the
oncology portfolio.. Develops budgets, schedules and performance
requirements. Builds long-term development and succession
plans.Contribution:
Collaborates with key stakeholders (e.g Internal- safety platform
lead,VP of safety, International Safety lead, VP of regulatory, SVP
development) - Applies influence and negotiation skills to drive
business results - Serves as important liaison to external
contacts. Education: MD or DO degree from an accredited medical
school with 6 years of work experience
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or
private practice (including hospital based) setting
AND
6 years of managerial experience directly managing people and/or
leadership experience leading teams, projects, programs or
directing the allocation of resources Preferred Education: ---
MD/PhD
--- Strong publication track record
--- Previous drug safety experience
--- Knowledge of clinical trials and drug development
--- Knowledge of all therapeutic area patient populations and drug
classes
--- Issue and crisis management Site Head, Global Safety, Oncology
- San Francisco Area Job Description: To lead the oncology
therapeutic area by providing strategic safety leadership and
expertise, continuous development and mentoring of TA staff,
logistic and other staff planning activities as warranted. Will
serves as the TA safety core member on select goverance governance
committees; and ensures the efficient functioning of the Global
Safety Teamsglobal safety framework. The Global Safety Executive
Medical Director TAH will lead by supervising and managing the
direction of the oncology portfolio:, including providing high
level safety strategy, personnel and resource management, mentoring
of staff, and providing cross-functional safety leadership at key
governance meetings. Responsibilities: ---Accountable for review
and approval of all regulatory responses or strategic GST
deliverables including but not exclusive to RMPs, PSURs, PSAPs,
GSSP, SARs
--- Represent TA in meetings with Management/governance boards,
regulatory agencies and external partners
--- Provide timely safety input to GRAAS Leadership, senior
management review committees, and governance boards as needed.
--- Provide functional expertise to guide the development of new
department and cross-functional processes
--- Advise and approve Individual Development Plans and Goals for
TA staff members
--- Work cross-functionally with Regulatory TA Heads to reach GST
issue resolution on safety related issues.
--- Monitor TA staff compliance with assigned SOP and compliance
training
--- Lead significant cross-functional projects or initiatives
Skills: --- Extensive knowledge of drug development (Non clinical,
clinical and CMC aspects), global pharmacovigilance principles,
commercialization, and safety escalation governance processes,
global regulatory authority operations, global rgulatory agency
submission process, technical skills (such as Microsoft Outlook,
Word, Excel, Power Point); ;and working globally.
--- Visionary strategic leadership abilities (Charts the course).
Proven track record as an effective team and strategic leader in a
Matrix environment (as well as working with a subsidiary company of
a larger organization). Issue and conflict management skills
required. Strong interpersonal skills needed to navigate cross
functionally between 2 companies and outstanding communication
skills including oral and written (medical writing) required.Also
must possess strong negotiation, critical thinking and problem
solving skills.
Competencies
Knowledge:
Accountable for budget and administration for sizeable operations
for a sub-function OR Accountable for budget and operations for a
medium-sized site. Collaborates with sub-functional leadership to
set strategy and business objectives. Problem Solving:
Establishes operational objectives for managers and/or teams of
professionals across the sub-function - Guided by functional
strategy. Provides authoritative advice to top management based on
deep subject matter expertise.Autonomy:
Leads a team of other global safety officers and safety scientists
who are accountable and responsible for the global safety of the
oncology portfolio.. Develops budgets, schedules and performance
requirements. Builds long-term development and succession
plans.Contribution:
Collaborates with key stakeholders (e.g Internal- safety platform
lead,VP of safety, International Safety lead, VP of regulatory, SVP
development) - Applies influence and negotiation skills to drive
business results - Serves as important liaison to external
contacts. Education: MD or DO degree from an accredited medical
school with 6 years of work experience
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or
private practice (including hospital based) setting
AND
6 years of managerial experience directly managing people and/or
leadership experience leading teams, projects, programs or
directing the allocation of resources Preferred Education: ---
MD/PhD
--- Strong publication track record
--- Previous drug safety experience
--- Knowledge of clinical trials and drug development
--- Knowledge of all therapeutic area patient populations and drug
classes
--- Issue and crisis management
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Keywords: TANNER & ASSOC INC, San Francisco , Site Head, Global Safety, Oncology - San Francisco Area, Healthcare , San Francisco, California
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