VP of Clinical Operations, Oncology

The VP of Clinical Operations, Oncology oversees three key functional areas (Clinical Operations, Data Management, and Clinical Trial Supply) to ensure efficient operation of clinical trials across Ascendis Pharma’s oncology pipeline.  An ideal candidate has hands-on experience in executing global oncology trials from early to late phases.  The candidate is expected to work cross-functionally to plan and execute global clinical trials, manage vendors, and ensure smooth collaboration across these three functional areas.  Additional responsibilities will include supporting development or amendments of clinical protocols and various documents associated with clinical trials along with providing strategic input for long-range strategic plans for the Ascendis Pharma oncology pipeline. 

The position is based in Palo Alto and reports directly to the EVP and Head of Clinical Development Oncology.

Key Responsibilities

·       Sets vision and direction through resource allocation decisions across 3 key functional areas of Clinical Operations, Data Management, and Clinical Trial Supply in Oncology. This position will be accountable and responsible for setting goals and expectations for deliverables across these functional areas to ensure achievement of objectives within Oncology while aligning with corporate strategy.

• Provides strategic and tactical insights on clinical operational aspects to the clinical development plans for Ascendis’ oncology programs
• Plans and leads end-to-end clinical operational activities to ensure efficient and high-quality clinical trial execution. Accountable for related corporate and departmental goals.
• Responsible for translating the company strategy to the functional Clinical Operations, CTS, and Data Management objectives to support corporate objectives. 

·       Accountable for long-term activities related to organization development and workforce planning for these functional areas.

·       Interacts regularly with other executives and key internal & external stakeholders. These interactions frequently involve highly visible activities such as speaking to or negotiating with multiple vendors, influencing other executives and/or academics, interacting with and responding to global health authority requests on behalf of the company.

Requirements

Knowledge, Skills and Experience

• BSc or MSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
• A minimum 15 years of related pharmaceutical development experience in Cinical Operations (with at least 6 years managing CROs) is required Must be able to demonstrate extensive experience in managing routine and unexpected challenges in the conduct of clinical studies. A minimum of 6 years previous management experience is preferred
• Proven ability to lead teams and strategic functional initiatives and change management activities
• Extensive experience from within the pharmaceutical industry or clinical research organizations working with cross functional teams and clinical development processes at every phase of development
• Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development in various regions of the world
• Solid understanding of US and Global regulations and guidelines (e.g. FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peers to support timeline and quality regulatory submissions
• Demonstrated excellent written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills
• Proven track record of translating senior level clinical research/scientific business requirements into operational strategies
• Strong strategic planning and decision-making skills
• Strong knowledge of Oncology clinical trials
• Experience leading and working in global/virtual teams
• Excellent verbal, written, analytical, and presentation communication skills.  Adept at communicating the Ascendis Oncology vision among direct reports and cross-functional teams, effectively aligning resources and motiving teams to achieve goals.  Must also can effectively communicate with colleagues and associates outside the organization to create partnership-style relationships
• May require occasional evening and/or weekend commitment
• Occasional domestic and international travel may be required (10-20%)

Compensation DOE, estimated $300-350K/year

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance