TA Portfolio Lead

PURPOSE: The Therapeutic Area (TA) Portfolio Lead plays a pivotal role in driving the operational strategy and planning for complex, large-scale clinical research portfolios. Key responsibilities include overseeing the TA portfolio ensuring regulatory adherence, and commercial potential in line with corporate objectives. The role demands expertise in clinical research, strong cross-functional collaboration, and strategic planning.

As the single point of accountability for TA delivery, the TA Lead ensures the successful execution of all clinical programs, managing risk, and proposing solutions as needed. This role also aligns TA goals with broader organizational objectives, working closely with leadership to operationalize strategy, optimize portfolio value, and foster an understanding of portfolio priorities across teams to enhance capability - building within the organization.

JOB RELATIONSHIPS:
Reports to: Chief Operating Officer

ESSENTIAL JOB FUNCTIONS:
A. Accountable for the delivery of the TA portfolio and ensures risk mitigation/escalation and mitigation of critical issues across assets is managed.
B. Develops project standards and ensures consistency and efficiency across the program.
C. Serves as key point of contact with portfolio clients.
D. Provide direction, advice and intellectual leadership to clients
E. Leverage experience and business acumen to identify strategic alternatives and approaches to client questions.
F. Provide follow-up with clients after project delivery to ensure satisfaction.
G. Ensure the development and delivery of client reports and presentations.
H. Proactively partners with cross-functional counterparts and external vendors to address
issues/concerns.
I. Identify improvement opportunities and bring forth best practices to support study execution within the portfolio and across the broader organization.
J. Holds high-level accountability for study execution.
K. Acts as an escalation point for all program work.
L. Frequently communicates program status to internal and external stakeholders, including Sr. Leadership.
M. Provide strategic leadership through continuous exploration and review of research, clinical, regulatory pathways, and facilitate the strategic perspective into program and portfolio plans
N. Execute, evaluate and continuously improve portfolio management governance structure. Guide the evolution of both portfolio and project governance and related tools. Source and integrate scalable platforms as company resources allow.
O. Identify key risks in collaboration with broader teams and guide risk mitigation strategies to ensure program success. Create and maintain a risk register outlining the risks, prioritization and risk mitigation strategies. Identify, surface and help resolve roadblocks and barriers encountered during program execution.
P. Establish and maintain a resourcing budget, forecast, and manage vendors (e.g., CROs) in
collaboration and alignment with Finance functions.
Q. Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities.
S. Additional duties as assigned by Management.
T. Utilizes expert judgment to make well-informed decisions, carefully weighing available data in environments with competing imperatives.
U. Establish architecture and governance to support development for lead program and portfolio programs.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:
A. Work is performed in a remote office setting.
B. Travel may be required up to 50%.
C. Daily computer use.
D. Occasional evening and weekend work schedules.
E. Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
F. Ability to drive and daily availability of an automobile.

MINIMUM REQUIREMENTS:
Education: Bachelor's degree required. Advanced degree preferred.
Experience: 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or
related healthcare sales experience

Knowledge and Skills:
A. Exceptional knowledge of clinical research methods is preferred.
B. Expertise in the oversight of clinical trials/ portfolios with demonstrated focus on enterprise
performance to bring value and efficiency to an organization.
C. Expert knowledge of ICH/GCP guidelines and FDA regulations and clinical operations development processes.
D. Expertise in the oversight of clinical trials/ portfolios with demonstrated focus on enterprise
performance to bring value and efficiency to an organization.
E. Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environments is required.
F. Advanced project management skills.
G. Strong presentation skills.
H. Self-starter, with a strong work ethic and outstanding communication skills
I. Proven teambuilding skills and the ability to lead partnerships across projects and multidisciplinary teams.
J. Demonstrated ability to build and implement portfolio management capability.
K. Demonstrated ability to collaborate and align with operations.
L. Excellent oral and written communication skills.
M. Excellent computer skills to include Office365 products.
N. Strong problem solving, risk assessment and impact analysis abilities.
O. Demonstrated experience in process improvement.
P. Flexible and able to multitask and prioritize competing demands.
Q. Ability to think independently and influence when appropriate.