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Director, Trial Oversight

Plano, TX, USA | Planet Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
  • Experience:
    12-15 years
Job Description:
90 people have viewed this job

POSITION SUMMARY:


As a senior member of the Clinical Program Operations team, the Director is 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. A key focus will be the oversight of and interactions with study managers as they manage CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives throughout study start-up, conduct and close-out.

RESPONSIBILITIES:


Accountable for the operational delivery of studies across programs, overseeing cross-functional alignment, budget, and timelines

Participate in program strategy meetings, contributing the operational strategy of responsible program/studies

Leads efforts for the selection and oversight of external service providers, including CROs and other clinical vendors as necessary

Develops and manages clinical trial budgets, providing ongoing financial reporting and forecasting; oversees budgets and timelines for responsible programs

Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary

Participate in request and review of scope of work, budgets, vendor performance and issue escalation and resolution

Oversees 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 

Identifies and communicates study issues that will impact budget, resources and timelines.

Provides support/escalation point for study team leads as needed.

Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites

Participates 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

Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programsActively participates in and contributes meaningfully to Company’s approach to risk-based trial oversight

Participates 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 oversees 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

Mentors more junior team members

Leads and/or contributes 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

CORPORATE COMMITMENTS:


Demonstrates commitment and support for company goals, objectives and procedures

Represents by developing collaborative relationships with site personnel, colleagues and vendors

Demonstrates professionalism and adherence to moral, ethical and quality principles

Complies with applicable regulations, GCP and corporate policies and procedures

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.

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

Technical/Software – Working knowledge and experience with Word, PowerPoint and Excel

INDUSTRY REQUIRED QUALIFICATIONS


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.

Requirements:

CORPORATE COMMITMENTS:


Demonstrates commitment and support for company goals, objectives and procedures

Represents by developing collaborative relationships with site personnel, colleagues and vendors

Demonstrates professionalism and adherence to moral, ethical and quality principles

Complies with applicable regulations, GCP and corporate policies and procedures

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.

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

Technical/Software - Working knowledge and experience with Word, PowerPoint and Excel

INDUSTRY REQUIRED QUALIFICATIONS


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


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