South San Francisco
California, United States of America
GENERAL POSITION SUMMARY/ PURPOSE:
Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Medical Director for Cancer Immunotherapy participates in development of the Clinical Development (CD) strategy for atezolizumab and/or tiragolumab and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Medical Directors may have one or more direct reports. PD Medical Directors are expected to perform their responsibilities with more independence by comparison to Associate PD Medical Directors, including participating in health authority (HA) interactions with little to no supervision from their managers.
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:
1. Cross-Functional Team Leadership & People Management
Participates in and/or leads the relevant Clinical Science Team (CST)
Can lead and/or otherwise represents CD in sub-teams (e.g. Study Management Teams) relevant to assigned
molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and
efficient CD plan execution
When assigned/appointed, can act as the Global Development Leader (GDL). Where assigned/appointed, expected
to represent CD on core teams, e.g., Lifecycle Team (LCT)
Accountable for training new CST members
May also, as appropriate, support relevant sub-teams in assigning and training new team members
As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures,
systems, tools and other resources
As needed or otherwise appropriate, assists with CD recruitment, training, and/or coaching of new or less experienced CD
Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training,
developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures
2. Global Clinical Development Planning
Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease
area(s) of assignment
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups
May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to
provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these
Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase
IIIB protocols and other information and provide CD input
May also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these
potentially relate to the assigned therapeutic/disease area(s)
Participates in CD strategy development and may present to various internal committees
Develops and provides clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the
Integrated Development Commercialization Plan (IDCP)
Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:
o Seeks guidance from his/her manager, as and when needed, to ensure appropriate design and development of the CD plan
3. Clinical Development Plan Implementation
Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche
Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment
Responsible to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target
Completes and/or leads other special projects, as and when assigned, or otherwise requested
Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, Roche
Standard Operating Procedures (SOPs) and other guidelines
QUALIFICATIONS & EXPERIENCE:
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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