Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

The Medical Director of Clinical Research, Oncology Development, provides medical guidance and leadership in the design, implementation, monitoring and interpretation of clinical trials conducted in patients with malignancies. These clinical trials will most often involve the development of new chemical entities (small molecules and biologics) with therapeutic potential. However, some clinical trials may involve the assessment of diseases and/or standard therapies, with the aim of better understanding disease pathophysiology, potential therapeutic targets, and markers of drug action and disease modification.

The Director will also provide clinical guidance to oncology projects in preclinical development and to compounds being evaluated for in-licensing to insure that those projects appropriately address unmet medical needs and are clinically feasible. The Director is also expected to present clinical data, plans and strategy at internal cross-functional meetings that may require such input. He or she is expected to be able to represent a given project at external meetings, e.g., at academic symposia and meetings with regulatory authorities.

Duties and Responsibilities:

Develops and writes clinical development plans for new chemical entities, from first-in-man to regulatory approval.

Integrates pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics and regulatory strategy into the clinical development plan with appropriate cross-disciplinary support.

Develops phase I, II, and III clinical protocols.

Identifies clinical investigators and coordinates their activities in the conduct of clinical trials and advisory board meetings.

Assists in the development of case report forms used to capture data from clinical protocols.

Provides guidance for clinical data organization and interpretation.

Monitors clinical trials for safety and, when appropriate, efficacy. Works in conjunction with Product Safety to insure timely reporting of safety signals to regulatory authorities and to Millennium.

Supervises and is accountable for the generation of clinical study reports.

Works closely with other functional areas within the Clinical Department (clinical operations, data management, biostatistics, clinical pharmacology, molecular medicine) to facilitate the execution of clinical trials.

Provides clinical sections for INDs, Annual Reports, and NDAs.

Participates in external relationships, e.g., with CROs, other pharmaceutical sponsors, and key opinion leaders.

Qualifications:

Basic qualifications:
Medical degree (MD, DO) from an accredited institution.

Board certification (e.g., internal medicine, pediatrics, surgery) or foreign equivalent.

Board certification in medical oncology and/or hematology, or foreign equivalent.

Experience in patient care: 5 or more years after obtaining MD (e.g., 3 years of internship and residency, 2 years of fellowship training or post-residency practice).

Preferred qualifications:
Must exhibit the ability to clearly communicate, be comfortable with public speaking and have facility with written communication.