Clinical Project Lead

3 weeks ago

Wokingham, United Kingdom Planet Pharma Full time

Position: Clinical Project Lead

Contract: 12 months initial contract with possibility of extension

Location: 3 days in the office in Wokingham and 2 days from home

Company: A Global Biopharmaceutical Company


Purpose:

The Clinical Project Lead is responsible for guiding the development and execution of exploratory and biopharmaceutics clinical plans at a molecule level. This role provides technical leadership and operational oversight of clinical research trials within the development framework. The Program Lead ensures timely, on-budget planning and delivery of clinical milestones throughout the molecule’s lifecycle. They serve as the single operational point of contact across the global clinical trial spectrum—from trial design through execution and closure—including timeline management, outsourcing, vendor oversight, patient recruitment and retention, and budget management.

Depending on the operational model chosen and the program’s needs, additional trial-level management support may be provided by internal or external resources. The Program Lead will continuously seek and apply knowledge from both internal and external sources to enhance development plans and identify improvement opportunities.


Primary Responsibilities:

Scientific and Therapeutic Area Expertise

  • Lead clinical asset strategy development for Phase 1, utilizing quality decision-making principles.
  • Deep understanding of the assigned therapeutic area, trial designs, and best practices to address execution challenges.
  • Offer guidance for clinical and regulatory documents (e.g., study protocols, risk profiles, briefing documents, New Drug Applications).
  • Stay current with relevant disease states, competitor activities, industry trends, and best practices.
  • Maintain knowledge of operational requirements for successful clinical studies and submissions (e.g., First Human Dose requirements).

Clinical Project Management

  • Lead the implementation of clinical project management processes and tools.
  • Collaborate with third-party organizations (TPOs) to deliver key trial outcomes.
  • Develop and maintain clinical plan timelines, communicating progress to the broader molecule team.
  • Coordinate with financial and cross-functional partners to manage the clinical budget at the molecule level.
  • Identify and communicate clinical risk assessments, and develop contingency plans for the team and stakeholders.

Clinical Operations

  • Oversee clinical trial operations, ensuring project milestones are achieved on time and within budget.
  • Create and manage timelines for clinical trial activities.
  • Participate in vendor selection and management, ensuring timely and budget-compliant project delivery.
  • Serve as the point of contact for clinical implementation issues and risk assessments, facilitating effective communication.
  • Partner with regulatory and medical teams to implement safety monitoring processes.

Communication and Team Management

  • Foster a quality-focused environment within the clinical team, documenting key decisions, actions, and scope changes.
  • Manage partnerships and integration with the clinical team and leadership in governance forums.
  • Effectively communicate and influence at all levels to support decision-making across teams and stakeholders.

Leadership

  • Collaborate effectively across all levels and support delivery through others.
  • Excel in problem-solving and navigating ambiguity to guide molecule-level strategies from inception to completion.
  • Exhibit strong persuasion, influence, and negotiation skills in a matrixed environment.
  • Encourage learning agility, strategic thinking, and innovative approaches to incorporate new insights.
  • Provide constructive coaching and feedback to colleagues.


Minimum Qualification Requirements:

  • Bachelor’s degree in a scientific field from an accredited institution.
  • 3+ years of experience in the pharmaceutical industry with direct experience in managing clinical studies, preferably in exploratory and biopharmaceutics development (5+ years preferred).
  • Strong knowledge of regulations and guidelines for clinical trials.
  • Proven ability to manage TPOs to deliver trial-level objectives.
  • Experience with project management tools and processes.
  • Effective cross-cultural communication skills and experience in a virtual work environment.
  • Demonstrated problem-solving abilities with a proactive approach to identifying and resolving systemic issues.
  • Strong organizational, interpersonal, and self-management skills.
  • Excellent communication skills, both written and verbal, with proficiency in Microsoft Office tools.
  • Ability to travel (up to 10%).


Other Information/Additional Preferences:

  • Advanced scientific degree.
  • Experience in exploratory and biopharmaceutics clinical development.
  • Experience in vendor management and contracting.
  • Proven experience in coaching and mentoring.
  • High-level computer skills (e.g., word processing, spreadsheets, presentations).

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