What are the responsibilities and job description for the Director, Clinical Development, Hematology/Oncology position at Jazz Pharmaceuticals?
Jazz Pharmaceuticals is a global biopharma company dedicated to transforming lives of patients and their families. We develop life-changing medicines for people with serious diseases, often with limited or no therapeutic options.
Our portfolio includes leading therapies for sleep disorders and epilepsy, as well as growing treatments for cancer. Our patient-focused approach powers pioneering research and development advancements in oncology and neuroscience.
Our international presence spans multiple countries, with headquarters in Dublin, Ireland, and research laboratories, manufacturing facilities, and employees serving patients worldwide.
Our focus areas include sleep and hematology/oncology, where we have a deep understanding of the patient journey and a suite of products and candidates to address critical needs.
Director, Clinical Development
This role joins our rapidly-growing Hematology/Oncology Therapeutic Area team. The Director will provide clinical leadership, medical input, and scientific oversight for global clinical development plans and protocols.
Responsibilities include:
- Providing leadership and medical input for clinical programs, protocols, trials, reports, and regulatory documents
- Collaborating closely with team members in clinical development, operations, biostatistics, regulatory, pharmacovigilance, early development, and other functions
- Serving as medical monitor on trials for products under development in Hematology/Oncology, making recommendations based on safety findings, and collaborating with CROs and study investigators
- Reviewing, interpreting, and approving safety and efficacy data in clinical study reports, regulatory documents, and submissions
- Providing strategic input on new product concepts, long-range plans, and life-cycle management opportunities
- Engaging external experts to obtain scientific input and integrate current clinical practice and guidelines into global clinical development plans
- Building, maintaining, expanding, and managing external relationships with outside collaborators, clinical investigators, and cooperative groups to support the clinical development program
Requirements include:
- 3 years academic and/or pharmaceutical industry experience
- Demonstrated expertise in Hematology/Oncology global clinical development
- Excellent oral and written communication skills
- Knowledge of GCP, Drug Safety, MedDRA safety coding, and Pharmacovigilance processes
- Values-based leadership evident in personal interactions at all levels
- Proactive and effective work style, with creative problem-solving skills
- Ability to travel (up to 30-40%)
Preferred qualifications include an MD or equivalent, Board Eligibility/Certification in Hematology and/or Medical Oncology, and US licensure and/or clinical practice experience.