Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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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:
Qualifications:
Education:
**CO/NY candidates may not be considered
Director, Project Lead
Posted: 04/06/2023
2023-04-06
2023-05-19
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
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