Dir Portfolio Delivery; AES

Summarized Purpose:

Oversee and set the strategy for the global study portfolio within one or more therapeutic areas (usually moderate to high complexity) and act as subject matter expert and first point of escalation for the business on this level from operational perspective. Develop and contribute to relevant therapeutic area trainings and standards. Bring in internal and external specialists for training purposes and utilize other methods to strengthen overall therapeutic area expertise and networking abilities among the assigned staff members. Oversee and report on project and therapeutic area performance and delivery of all studies and their status within the therapeutic area(s) with the overall goal to keep all studies moving towards successful completion as per contractual commitment.

Drive delivery and create a cadence of accountability on a per project basis across territories and regions, with feedback loops into delivery components across the organization. Interpret global and cross-study metrics and data on complex issues and make good business decisions with minimal support. Acts as liaison between all centralized functions and site operations to deliver consistent and efficient performance on a project and portfolio level.

Represent the department and therapeutic area in cross-functional, cross-territory and cross-regional initiatives that enhance business objectives.

May support other departments as a subject matter expert to win new business (bid defense and proposals).

· Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime (if applicable).

· Provides ongoing training as needed to ensure staff mastery of systems, procedures and therapeutic area expertise and network expansion.

· Ensures maintenance of profitability by ensuring clinical activity is conducted within contract scope, through efficient management of therapeutic area portfolio(s) and guidance to staff. Evaluates out of scope work and assists with contract modifications as needed.

· In close collaboration with other line managers depending on therapeutic area assigment, allocates staff to projects and focuses workload assignments to ensure effective project allocation, optimize collaboration with stakeholders, cultivate talent, and promote staff retention by implementing actions and communications aimed to motivate and engage.

· Oversees and sets the operational and enrollment strategy as well as patient pathway and profile for the global study portfolio within one or more therapeutic areas (usually moderate to high complexity) and act as subject matter expert and first point of escalation for the business on this level from operational perspective.

· Ensures the timely execution of study deliverables with a destinct focus on the assigned therapeutic area(s). Supports staff to develop and drive specific and overall project/program strategies to ensure optimum performance by achievement of annual plans and targets. Holds regular therapeutic area-specific project review meetings with staff to identify potential clinical and financial project risks, ensuring contingency plans and solutions are in place and appropriate timely escalations are conducted. Liaises with cross functional leaders to drive study deliverables at global project and therapeutic area level.

· May support other departments as a subject matter expert to win new business (bid defense and proposals).

· Supports a culture of immediate action and proactive escalation including early escalation to present solutions to risk, effective interaction with stakeholders, and effective management of general quality risk.

· Within their therapeutic area(s) expertise, supports the business with quality issues, QA audits, and facilitates client and internal quality assurance audits as required.

· Provides cross-functional (in-country and/or regional) leadership in all aspects of assigned study revenue generating contract delivery.

· Assists in ensuring site readiness within therapeutic area(s). Arrange and facilitate (in conjunction with Medic and/or KOL in therapeutic area) therapeutic area(s) training for site staff and Investigators. Consult in the identification, of equipment/procedures needed.

· May contribute in the development of SOPs and associated documents, as needed.

· Participates in cross-functional, cross-country and cross-territory projects or initiatives as needed. Ensures implementation of lessons learned within therapeutic area(s) improve the overall business and delivery on future studies.

Summarized Purpose:

Oversee and set the strategy for the global study portfolio within one or more therapeutic areas (usually moderate to high complexity) and act as subject matter expert and first point of escalation for the business on this level from operational perspective. Develop and contribute to relevant therapeutic area trainings and standards. Bring in internal and external specialists for training purposes and utilize other methods to strengthen overall therapeutic area expertise and networking abilities among the assigned staff members. Oversee and report on project and therapeutic area performance and delivery of all studies and their status within the therapeutic area(s) with the overall goal to keep all studies moving towards successful completion as per contractual commitment.

Drive delivery and create a cadence of accountability on a per project basis across territories and regions, with feedback loops into delivery components across the organization. Interpret global and cross-study metrics and data on complex issues and make good business decisions with minimal support. Acts as liaison between all centralized functions and site operations to deliver consistent and efficient performance on a project and portfolio level.

Represent the department and therapeutic area in cross-functional, cross-territory and cross-regional initiatives that enhance business objectives.

May support other departments as a subject matter expert to win new business (bid defense and proposals).

· Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime (if applicable).

· Provides ongoing training as needed to ensure staff mastery of systems, procedures and therapeutic area expertise and network expansion.

· Ensures maintenance of profitability by ensuring clinical activity is conducted within contract scope, through efficient management of therapeutic area portfolio(s) and guidance to staff. Evaluates out of scope work and assists with contract modifications as needed.

· In close collaboration with other line managers depending on therapeutic area assigment, allocates staff to projects and focuses workload assignments to ensure effective project allocation, optimize collaboration with stakeholders, cultivate talent, and promote staff retention by implementing actions and communications aimed to motivate and engage.

· Oversees and sets the operational and enrollment strategy as well as patient pathway and profile for the global study portfolio within one or more therapeutic areas (usually moderate to high complexity) and act as subject matter expert and first point of escalation for the business on this level from operational perspective.

· Ensures the timely execution of study deliverables with a destinct focus on the assigned therapeutic area(s). Supports staff to develop and drive specific and overall project/program strategies to ensure optimum performance by achievement of annual plans and targets. Holds regular therapeutic area-specific project review meetings with staff to identify potential clinical and financial project risks, ensuring contingency plans and solutions are in place and appropriate timely escalations are conducted. Liaises with cross functional leaders to drive study deliverables at global project and therapeutic area level.

· May support other departments as a subject matter expert to win new business (bid defense and proposals).

· Supports a culture of immediate action and proactive escalation including early escalation to present solutions to risk, effective interaction with stakeholders, and effective management of general quality risk.

· Within their therapeutic area(s) expertise, supports the business with quality issues, QA audits, and facilitates client and internal quality assurance audits as required.

· Provides cross-functional (in-country and/or regional) leadership in all aspects of assigned study revenue generating contract delivery.

· Assists in ensuring site readiness within therapeutic area(s). Arrange and facilitate (in conjunction with Medic and/or KOL in therapeutic area) therapeutic area(s) training for site staff and Investigators. Consult in the identification, of equipment/procedures needed.

· May contribute in the development of SOPs and associated documents, as needed.

· Participates in cross-functional, cross-country and cross-territory projects or initiatives as needed. Ensures implementation of lessons learned within therapeutic area(s) improve the overall business and delivery on future studies.Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years).

5 years of management responsibility

Strong leadership skills

Knowledge, Skills and Abilities:

· Excellent & effective mentoring/leadership skills

· Effective organizational and negotiation skills; effective at multi-tasking

· Superior interpersonal skills and proven ability to be creative in problem solving and conflict resolution

· Capable of utilizing problem-solving techniques applicable to constantly changing environment

· Experienced in motivating, integrating individuals/teams, inducting, coaching and teaching

· Proven record to proactively direct and promote teamwork in a multi-disciplinary and/or multi-cultural team setting

· Expert knowledge of clinical trials in releveance to regulations and guidelines e.g. ICH/GCP, FDA guidelines, etc

· Outstanding knowledge of one or more therapeutic areas including associated disease models and treatment options as well as a strong network of clients, vendors specialists and others working in this therapeutic coupled with the ability to transfer this knowledge in an efficient and meaningful manner to others

· Excellent ability to evaluate medical research data, demonstrate proficient knowledge of medical terminology and therapeutic areas

· Proficient knowledge with company practice and processes to provide guidance and direction

· Proficient in using company tools to ensure oversight of financial management of projects, as well other tools needed to manage the timelines and quality of the data

· Strong attention to detail

· Competent use of computer and company systems to manage performance

· Strong attention to detail, ability to synthesisze and communicate complex information

· Strong knowledge of English language & grammar with effective written and oral communication skills

Management Role:

Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.

Working Conditions and Environment:

· Work is performed in an office environment with exposure to electrical office equipment.

· Occasional drives to site locations, frequent travels both domestic and international.

Physical Requirements:

· Frequently stationary for 6-8 hours per day.

· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

· Moderate mobility required.

· Occasional crouching, stooping, bending and twisting of upper body and neck.

· Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

· Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

· Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.

· Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration.

· Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

· Regular and consistent attendance.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years).

5 years of management responsibility

Strong leadership skills

Knowledge, Skills and Abilities:

· Excellent & effective mentoring/leadership skills

· Effective organizational and negotiation skills; effective at multi-tasking

· Superior interpersonal skills and proven ability to be creative in problem solving and conflict resolution

· Capable of utilizing problem-solving techniques applicable to constantly changing environment

· Experienced in motivating, integrating individuals/teams, inducting, coaching and teaching

· Proven record to proactively direct and promote teamwork in a multi-disciplinary and/or multi-cultural team setting

· Expert knowledge of clinical trials in releveance to regulations and guidelines e.g. ICH/GCP, FDA guidelines, etc

· Outstanding knowledge of one or more therapeutic areas including associated disease models and treatment options as well as a strong network of clients, vendors specialists and others working in this therapeutic coupled with the ability to transfer this knowledge in an efficient and meaningful manner to others

· Excellent ability to evaluate medical research data, demonstrate proficient knowledge of medical terminology and therapeutic areas

· Proficient knowledge with company practice and processes to provide guidance and direction

· Proficient in using company tools to ensure oversight of financial management of projects, as well other tools needed to manage the timelines and quality of the data

· Strong attention to detail

· Competent use of computer and company systems to manage performance

· Strong attention to detail, ability to synthesisze and communicate complex information

· Strong knowledge of English language & grammar with effective written and oral communication skills

Management Role:

Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.

Working Conditions and Environment:

· Work is performed in an office environment with exposure to electrical office equipment.

· Occasional drives to site locations, frequent travels both domestic and international.

Physical Requirements:

· Frequently stationary for 6-8 hours per day.

· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

· Moderate mobility required.

· Occasional crouching, stooping, bending and twisting of upper body and neck.

· Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

· Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

· Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.

· Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration.

· Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

· Regular and consistent attendance.