Seeking an MD with at least two years of industry experience to work on a late stage molecule for ulcerative colitis and Crohn’s disease. Multiple ongoing Phase 3 studies with data readouts for ulcerative colitis next year.
Cross-Functional Team Membership
Participates in 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 clinical development (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
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 staff members
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
Can collaborate 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.
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
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)
Participates in implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:
Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders
Clinical Development Plan Implementation
Provides clinical support across all relevant studies and programs:
Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
Collaborates with others in the development of the product safety profile
Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
Represents, alongside his/her manager or others, Roche in key investigator and other external presentations, meetings and other communications
Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study
Acts as a medical monitor for assigned studies
Conducts and coordinates ongoing reviews of medical/safety data
Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
Collaborates with other groups to ensure timely and appropriate completion of interim study reporting
Collaborates with clinical operations to close-out clinical studies, secure data and complete study reporting
Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting
Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
Develops and delivers key presentations to convey the CD perspective and provide updates on strategies, plans and other activities
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 relevant medical experience in Gastroenterology, Internal Medicine, or related field
2 or more years pharma/biotech industry experience
2 or more years 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
Familiar with competitive activity in the field
Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
Has 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%)
Who We Are
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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