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Director, Project Lead

Plano, TX 75063

Posted: 04/06/2023 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 541845-1 Is job remote?: Yes Country: United States

Job Description


Job Summary:
As a senior member of the Clinical Program Operations team, you will be responsible for ensuring the strategic planning, oversight and execution of clinical studies in multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Director, Project Lead effectively leads a team of direct reports including Clinical Study Managers, Clinical Site Managers, Clinical Trial Associates, and other key operational team members, in order to ensure successful execution of clinical trials.    

Job Responsibilities:
  • Accountable for the operational delivery of studies across programs, overseeing cross-functional alignment, budget, and timelines
  • Ensure appropriate growth of the department, specific to a given compound, to ensure delivery of clinical trial data in alignment with corporate objectives.
  • Participate in program strategy meetings, contributing the operational strategy of responsible program/studies
  • Lead efforts for the selection and oversight of external service providers, including CROs and other clinical vendors as necessary
  • Develop and oversee the management clinical trial budgets by CSMs, providing ongoing financial reporting and forecasting oversight; oversees budgets and timelines for responsible programs
  • Participate in request and review of scope of work, budgets, vendor performance and issue escalation and resolution
  • Oversee conduct of studies within agreed timelines and in accordance with internal SOPs and GCP, and coordinates cross functional efforts to achieve study objectives and goals
  • Identify and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed.
  • Prepare potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites
  • Oversee and participate in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required
  • Actively participate in and contributes meaningfully to Company’s approach to risk-based trial oversight
  • Participate in the ongoing cross-functional Oversight Review Committee meetings
  • Collaborate closely with the assigned study manager to effectively support assigned studies
  • Oversee clinical study managers and study teams to ensure top quality execution of clinical programs
  • Ensure clinical inspection readiness, for all aspects of FDA and EMA audits
  • Ensure excellent vendor management and oversight by the study teams, and appropriate documentation to demonstrate the department’s approach
  • Strategically oversee the resourcing across programs, including personnel and capital expenditures (study managers, CTAs, contract CRAs, administrative support, software investments including CTMS, eTMF, etc.)
  • Works with study teams to ensure Trial Master File is accurate and up to date
  • Mentor junior team members, including CSMs and CTA
  • Lead and/or contribute to department initiatives, and assists in the design and implementation of standardized work processes
  • Effectively collaborate with HR, Finance, Accounting, Regulatory, QA, Bioinformatics, Legal, Medical/Clinical Development, IT, and other departments
  • Other duties as assigned

Qualifications:
  • Integrity & Judgement – Must have a strong commitment to integrity and the importance of honoring others in the workplace, yet be willing to practice candor and forthrightness.  Must have great discernment and perceptiveness in decision making.
  • Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.  Demonstrated effective team leadership.
  • Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences. 
  • Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision.
  • Strategic Thinking – Strong capability of strategic thinking and proposing innovative solutions to issues.  Visionary approach to department planning, professional development, and tactical solutions.
  • Collaboration & Teamwork – Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.  
  • Technical/Software - Working knowledge and experience with Word, PowerPoint and Excel
  • A minimum of 12 years of pharmaceutical or biotech-related experience 
  • Demonstrated experience in core and technical aspects of clinical trial conduct, which may include Site, CRO, Pharma, Biotech, and/or IRB related experience
  • GCP and regulatory knowledge including FDA and ICH regulations
  • The ideal candidate has at least 5 years of experience overseeing clinical operations (or in leadership positions within clinical operations) at a small biotech or pharmaceutical company, has a breadth and depth of clinical operations knowledge, and is ready to step into a leadership role.
  • Experience in Metabolic Disease and Pain (diabetes, kidney disease, DPN or other pain indications).

Education:
  • Bachelor’s Degree or Master’s in sciences, health, or related area (advanced degree preferred)


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Plano, TX

Looking for exciting job opportunities in the Plano, Texas area? Discover your next career move in this vibrant city nestled in the heart of the Lone Star State. Plano offers a perfect blend of urban conveniences and natural beauty, with a booming economy and a welcoming community. With renowned companies calling Plano home, including Toyota and Liberty Mutual, endless growth opportunities await. Explore the thriving arts scene at the ArtCentre of Plano, catch a live performance at the Courtyard Theater, or indulge in the unique flavors of Tex-Mex cuisine at local eateries. With easy access to parks like Arbor Hills Nature Preserve and exciting attractions like Legacy West, Plano gives you a perfect work-life balance. Join us in Plano and unlock a world of possibilities for your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.