Global Clinical Project Leader

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding.

In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

Overview

The Global Clinical Project Leader will provide overarching management of clinical trial execution for the assigned clinical development program. The incumbent will be responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program.

The incumbent will be responsible for employing risk-based management strategies, implementing solutions, and providing accurate and timely information on the program and fostering continuous improvement in clinical development.

Responsibilities

Develop and deliver on operational component of the clinical development plan in consultation with key stakeholders, including:

High level resource planning

High level budget oversight

Clinical drug supply requirements

Development of clinical program standards; and Assessing impact of any proposed changes to the program

Oversee matrix relationship with assigned Clinical trial Managers, Data Managers, and other members of the Clinical Project Team; ensure consistent execution across the program, deliver a development package of adequate quality for product registration.

Represent development operations in cross-functional strategy and program team meetings.

Detect possible operational issues/risks in the clinical development programs and assist CTMs in developing mitigation plans. Propose and implement solutions to issues/risks.

Provide accurate and timely information on the program.

Facilitate continuous improvement in clinical development.

Stay abreast of clinical operations developments, methods, and technologies related to the biotechnology/pharmaceutical industry. Make strategic and tactical recommendations to provide and ensure competitive advantage to the company.

Other job-related duties as assigned.

Qualifications

Completed BS degree or equivalent, with a minimum of 8 years pharmaceutical or biotechnology industry experience; or completed MS degree or equivalent with a minimum of 6 years pharmaceutical or biotechnology industry experience, at least 2 of which must have been at the Senior Clinical Trial Manager or equivalent position.

Planning and managing complex and/or strategic priority clinical programs.

Dermatology and Allergy experience preferred.

Technology aptitude (project management, eTMF, etc.)

Experience with data review, analysis, and interpretation of  knowledge of the drug development and commercialization process (from protocol writing to medical results reporting and submissions.)In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations.

Proven people management expertise.

Ability to effectively influence without hierarchical authority.

Flexibility and drive for results - willingness to embrace change and be able to work in a changing environment while…