Graham's List

#4 Associate Director/Director Clinical Development



Corporate Profile:

A biotech company acquires, develops, and commercializes innovative products for the treatment of important unmet medical needs in cancer and immunological diseases.

We are committed to P3C:

• People: Building a world-class team and leading core competencies in clinical, regulatory, and business development.

• Products: Accelerating the development of lead product candidates, PT-523 and IPdR.

• Pipeline: Expanding our pipeline by being the partner of choice for suppliers, researchers, and alliance partners.

• Culture: Nurturing a unique company culture focused on patients, developing extraordinary team members, creating high performing teams, and seeking goodness and grace in others with the highest standards of integrity.

Functions:

Reporting to the VP/Chief Medical Officer, the Assoc Director/Director, Clinical Development will have responsibility for creating and implementing clinical development plans for lead product candidates in Hana’s pipeline. Effectively interacting with medical experts, regulatoryagencies, Hana development partners and the internal HHS team, the position will have responsibility for the oversight of early stage clinical trials through NDA approval. Managing clinical trials either directly or through a CRO, he or she will oversee the design, preparation and initiation of study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice. The person will be responsible for the analysis and interpretation of study data and preparation of reports for FDA authorities and for publication. Developing relationships with key thought leaders to support product development, he or she will represent HHS externally in applicable scientific, medical and regulatory forums.

Qualifications:

An NP, PharmD, and/or PhD, preferably with industry experience in clinical development, he or she will have participated in the submission of successful registrational trials. A superb manager, he or she will also possess the ability to work well as part of a team. The team should have successful networking relationships with opinion leaders and investigators in the field of oncology. He or she will have excellent leadership, performance management and communicatio skills.