South San Francisco, California
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 participates in development of the Clinical Development (CD)strategy 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.
1. Cross-Functional Team Membership
• Participates in and/or leads the relevant Clinical Science Team (CST)
• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
• As requested, supports the CST lead and overall team with training new CST members
• May also, as appropriate, support relevant sub-teams in training new team members
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, regulatory, business development, commercial operations, legal, etc.
• Participates in CD strategy development
• Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development 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
• As assigned, 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 development of the CD plan for assigned molecule(s)/indication(s) and/or other programs:
• Supports other CST members in preparing for HA meetings and, as appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients.
3. Clinical Development Plan Implementation
• Provides clinical support across all relevant studies and programs:
• Develops presentations to convey the CD perspective and provide updates on strategies, plans and other activities
• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment
• Completes other special projects, as and when assigned, or otherwise requested
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as
“preferred,” or as a “plus,” all points listed below are considered minimum requirements.
QUALIFICATIONS & EXPERIENCE:
• M.D. with fellowship training in rheumatology
• Pharma/biotech industry experience OR is a recognized expert in the field
• Experience with clinical trials across Phase II – III drug development
• Academic/teaching background is a plus
• Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
• Experience developing product and safety profiles
• Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant
guidelines and regulations
• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
• Outstanding attention-to-detail
• Has working knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
• Good interpersonal, verbal communication and influencing skills; can influence without authority
• Strong written communication skills
• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
• Works well within teams and is effective in collaborating with others internally and externally
• Ability to travel globally (<30%)
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
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