Program Lead, Clinical Delivery - FSP

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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Overview

The purpose of the Program Lead, Clinical Delivery is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. The Program Lead, Clinical Delivery is responsible for planning and delivering exploratory and biopharmaceutics clinical trial and submission milestones on time and on budget throughout the molecule lifecycle. The Program Lead, Clinical Delivery is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational deliverables), and budget management. The Program Lead will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities.

1. Scientific and Therapeutic Area Expertise

• Leads the development of the clinical asset strategy for phase 1 leveraging quality decision making principles.

• Understands assigned therapeutic area including trial designs, risks and execution challenges and best practices.

• Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports CSRs), abstracts, publications, and manuscripts.

• Stays up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.

• Maintains knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions e.g., FHD (First Human Dose) requirements, detail of operations to deliver critical path studies and submissions.

2. Clinical Project Management:

• Leads and has expertise in the implementation and integration of clinical project management processes and tools.

• Works with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables.

• Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.

• Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.

• Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates, and leadership.

3. Clinical Delivery:

• Accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget

• Create and manage implementation timeline and clinical trial activities

• Involved in selection process and management of vendors, ensuring day to day oversight for operational deliverables of external network of vendors to ensure on time and on budget clinical project deliverables

• Serves as the point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward

• Partner with regulatory and medical to ensure safety management and monitoring processes are implemented

4. Communication and Team Management:

• Influences and works with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources, and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.

• Manages key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).

• Effectively and reliably communicates and influences at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders

5. Leadership

• Collaborates effectively with colleagues at all levels; able to work with, and deliver, through others.

• Skilled at working through ambiguity and effective problem-solving/solution-oriented skills to help develop and evaluate molecule level strategies from lead to legacy.

• Successful in persuasion, influence, and negotiation skills in a matrix environment.

• Fosters spirit of learning agility, strategic thinking, and the ability to think differently to incorporate new learning

• Contributes to the development of others by being an active source of constructive coaching and feedback to co

workers.

For select Program Leads, Clinical Delivery, the following section will also apply

6. People Management

• Recruits, develops, and retains a diverse and highly capable workforce.

• Ensures robust individual training plans and timely completion of required training for direct reports.

• Supports and enables talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.

• Contributes to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.

• Models behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally.

• Seek opportunities to reward and recognize individuals and teams.

• Manages team workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies.

• Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models’ inclusivity to ensure diverse voices and ideas are heard and considered.

• Coaches and mentors department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.

Qualifications:

• Bachelor’s degree in a science related field from an accredited college or university.

• 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred).

• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.

• Ability to influence and oversee TPOs to enable delivery of trial level deliverables.

• Demonstrated knowledge and experience with project management tools and processes.

• Demonstrated ability to work effectively cross-culturally and in a virtual work environment.

• Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.

• Demonstrated problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent recurrence within the team.

• Strong self-management, organizational and interpersonal skills, and the ability to be flexible in varying environments and with multiple customer groups.

• Strong leadership and networking skills.

• Excellent oral and written communication skills; able to communicate clearly and with team members and leadership

• Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project

• Ability to travel (up to 10% expected)

Additional Preferences

▪ Advanced scientific degree

▪ Exploratory and biopharmaceutics clinical development experience preferred

▪ Vendor management and contracting experience.

▪ Proven experience of coaching and mentoring others.

▪ Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).