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Director/Sr. Director of Clinical Operations

3 months ago

Canada, CA PharmaIN Full time
Job Description
Director/Sr. Director, Clinical Operations
Oncology Program

POSITION TITLE: Director/Sr. Director, Clinical Operations
REPORTS TO: VP, Clinical Operations
POSITION TYPE: Full-time, exempt position

PharmaIN Corporation is a privately held clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, peptide-based therapies for liver diseases and in oncology.

We seek a highly motivated, results-oriented, collaborative and agile leader with global clinical operations and drug development experience who has a passion for operational excellence to fill our Director/ Senior Director (Sr. Director) position and to join our growing Clinical Operations group.

This position will manage and mentor Clinical Trial Manager(s), Clinical Research Associates, and Clinical Trial Assistants.

OVERVIEW:

The Director/Sr. Director will serve as the Clinical Operations lead for the oncology program. This position works closely with the Clinical Development Leads, Clinical Trial Manager(s), cross-functional groups and study team members to plan, implement, and carry out complex clinical trials with new and emerging therapeutics in the PharmaIN oncology portfolio.

You will effectively oversee the clinical operations of clinical trials in the oncology program and contribute to the department infrastructure build out and improvement initiatives. This position combines full-cycle trial planning, execution, and reporting of clinical trials across the oncology program with leadership; and works in project teams, study teams and across matrix teams of direct and indirect reports.

KEY RESPONSIBILITIES:

  • Results-driven oversight and hands-on management of the clinical operations team, with clearly established accountability to company leadership.
  • Develop and implement clinical operations strategy for the oncology portfolio, fostering excellence in cross-functional teams.
  • Plan, initiate, and execute clinical trials, optimizing trial design, recruitment, and data collection. to meet corporate goals and timelines.
  • Contribute to the writing and review of clinical documents
  • Develop and manage clinical operations budget, monitoring financial metrics and resource allocation across oncology portfolio.
  • Build and maintain program and study timelines, track milestones, and monitor overall operational performance metrics, and communicate to key stakeholders and upper management.
  • Lead strategy for identification, assessment, selection, engagement, management, and oversight of appropriate vendors, CROs, and site investigators. Manage CRO and vendor relationships, negotiating contracts for quality and efficiency. Analyzes CRO performance trends and resolves or escalates accordingly. Provide proactive and consistent oversight of vendor performance.
  • Cross-collaboration proficiency with other functions such as Pre-Clinical, Clinical Development, CMC, Bioanalytical, Project Management, and Business Development, etc.
  • Oversee and contribute to inspection readiness activities that support system reviews, audits and regulatory inspections related to clinical trial conduct.

DEPARMENT LEADERSHIP

  • Contribute to internal efforts to establish/improve departmental infrastructure, procedures, methods, techniques, and standards for projects, process, and staff.
  • Champion or contribute to Department initiatives.
  • Provide strong financial acumen necessary for the management of clinical trial budgeting.
  • Contribute to departmental business decisions, infrastructure planning and build out/implementation.
  • Demonstrate a deep understanding of industry trends and challenges, proactively translating them into specific steps at the clinical operations functional level.

SUPERVISORY & DEVELOPMENT

  • Set clear goals for the oncology clinical operations team members and direct reports. Coach direct reports on their performance, development, and career interests.
  • Provide supervision, management, and mentoring of Clinical Trial Manager(s), Clinical Research Associates and Clinical Trial Assistants, monitoring performance and deliverables.
  • Oversee and provide oversight and guidance to study teams and for team deliverables.
  • Ensure the competencies and skills required for the trial team are consistent with defined requirements and assigned roles.
  • Ensure all necessary departmental and project specific training is provided and up to date.

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Qualifications:
Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring. Experience in planning, conducting, managing, Phase 1-3 clinical trials, including multi-national clinical trials (e.g., Europe, Canada, Asia Pacific preferred).

  • Bachelor’s degree (or equivalent) in a relevant scientific field, with advanced degree or nursing degree preferred.
  • 10+ years of biotech/pharmaceutical clinical trial experience, with an extensive portion supporting liver and/or other complex diseases.
  • Minimum of 5 years of people management experience, including experience managing the work of other clinical, contract and CRO staff.
  • Extensive experience developing RFPs; selection of vendors and CROs and demonstrated successful and effective management of CROs and other trial related vendors in a results-driven culture.
  • Communicates with clarity (written and spoken) and possesses strong interpersonal skills both formal, and colloquial.
  • Resilient, creative, capable problem-solver; able to rapidly enter into action with a sense of urgency and thrive under time-sensitive conditions; driven by a desire to deploy innovative approaches and technologies to deliver efficiencies and value.
  • Thorough knowledge of ICH/GCP guidelines and appropriate regulatory guidelines; regulatory inspection experience preferred.
  • Previous experience selecting industry standard systems, such as trial master file systems, clinical trial management systems, data management systems (such as RAVE), etc.
  • Proficiency with MS Office Suite, SharePoint, TEAMs software platforms. Able to create program timelines in MS Project, SmartSheet, or similar platform.
  • This position requires up to 25% domestic travel and may include limited international travel. Current passport to allow international travel.

ESSENTIAL TRAITS

  • Willingness to “roll-up sleeves” and get work done to meet department and company goals and milestones.
  • Leads by example and learns from mistakes
  • Effectively pivots to meet changing demands in priorities
  • Clearly communicates milestones, risks, mitigations, and essential feedback
  • Comfortable communicating to stakeholders
  • Values the input of colleagues and is a collaborative team player
  • Works efficiently without compromising quality
  • Innovates and eliminates redundant, inefficient, and manual processes where feasible

Location: Our offices and labs are located in Bothell Washington, just north of Seattle. This position is a hybrid position with preference of location in greater Seattle area.

COMPENSATION:

This position has a compensation range dependent on qualifications and experience.

Director range: $180,000 to $230,000 annually
Sr. Director range: $210,000 to $265,000 annually

At PharmaIN we engage equitable workplace strategies to ensure fair compensation. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity, and alignment with current market data. We take care of our employees and offer generous benefit plans, flexible paid time off and competitive pay. We strive to make PharmaIN an environment where all employees can succeed.

The PharmaIN Team shares a passion for meaningful work and is committed to solving complex problems in liver diseases and in oncology to create new therapies for patients suffering with these diseases. We believe in innovative thinking, collaboration, flexibility, action, and healthy debate.

PharmaIN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. PharmaIN is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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