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:

Manages all aspects of an assigned clinical program(s) (globally) to ensure that all studies within the program are completed on time within budget and in compliance with SOPs, Regulatory regulations and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals.

Duties and Responsibilities:

Working with the MD, the Clinical Program Manager provides input to the development of the Clinical Development Plan (CDP).

Uses knowledge of therapeutic area and TA strategies and operational expertise to oversee the Clinical Sub-team for assigned molecules, takes a leadership role in the implementation/ execution of the CDP, and participates in the development of clinical trial protocol concept in collaboration with the sub-team.

Utilizes operational expertise, knowledge of TA strategy and TA scientific input when planning program feasibility, developing strategies for country selections, CRO/ vendor use and evaluations and planning for contingencies. May participate in business development evaluations from the clinical research and operational perspective as applicable.

In conjunction with the sub-team, contributes to creation, implementation and revision of the CDP; evaluates and ensures that CDP is feasible, (i.e., that the key clinical development milestones are achievable within the constraints of the available human resources and the proposed budget and timelines) and oversees implementation of CDP into study protocols.

Establishes and cultivates relationships with site investigators and Key Opinion Leaders, ensuring up-to-date knowledge of current clinical research landscape and operational feasibility in relevant indications and locations.

In conjunction with the sub-team, coordinates all relevant Clinical Development activities/documents related to Regulatory Submissions (e.g., IB, IND, Annual Reports, BLA, NDA or other regulatory filings).

Provides input into creation of program budget. Ensures Clinical Development portion of program is conducted within budget and identifies, escalates and/or resolves discrepancies.

Tracks and oversees all studies related to the program's CDP(s). Ensures consistency within all program studies, alignment to overall time lines and budgets, TA strategies and corporate objectives.

Provides mentoring, leadership and guidance to clinical trial management staff as well as direction and oversight on protocol development, associated clinical documents (e.g., CRFs, charters, etc.) and study execution, including ensuring that GCP principles are followed.

Participates in recruitment, development, and training of trial management staff. May have direct line management of program-related Clinical Trial staff.

Oversees the Clinical Trial Working Group (CTWG) strategy for site and vendor selection, and approves final investigator site and vendor selection for clinical trials at the program-level.

Ensures consistency and GCP compliance within all program clinical trials, and ensures alignment with the therapeutic area and commercial strategy.

Qualifications:

Basic Qualifications:
Must have experience in relevant therapeutic area. Bachelor's degree science required; must have excellent current knowledge of clinical research; must have proven excellence in cross-functional matrix or direct line management of clinical trial personnel.

Preferred Qualifications:
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development;
Excellent project management skills, including risk assessment and contingency planning. Also requires excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.

Education typically requires 8 years of global drug development with experience managing clinical projects within time, budget, and quality expectations;
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