(Senior) Medical Director Neuroscience, Gantenerumab

We are looking for an experienced and motivated MD to join our team as a Senior Medical Director (Medical Director). 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 the 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.

• Cross-Functional Team Membership
• Acts as Clinical Science Leader for the assigned molecule(s)/indication(s) (Senior MD)
• Participates in the relevant Clinical Science Team (CST) meetings
• Participates as a standing or ad hoc member in sub-teams relevant to the assigned molecule(s)/indication(s) and supports/lead (Senior MD) the CST with cross-functional integration, coordination, and alignment to enable effective and efficient CD plan execution
• As requested, supports the overall team with training new CST 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 to the assigned molecule(s)/indication(s)
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific molecule(s)/indication(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, etc.
• Participates in development of the CD plan for assigned molecule(s)/indication(s)
• Contribute to the preparation for HA meetings. Participates in HA meetings (Senior MD). Ethically, effectively and professionally represents the interests of Roche and patients.
• Supports with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
• Clinical Development Plan Implementation
• Provides clinical support across all relevant molecule(s)/indication(s) of assignment
• Closely collaborates with the molecule GDL
• Core member of the Global Development team (Senior MD)
• Designs and develops clinical studies for review and discussion with other CST members and development team
• Collaborates with others in the development of clinical sections of investigator brochures, presentations, and other materials
• Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
• Participates in investigator and other external presentations, meetings, and other communications
• Acts as a medical monitor for assigned studies
• Conducts 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
• Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting
• Participates in the development and implementation of communications strategies to support existing and concluded studies. This includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs), and other guidelines

QUALIFICATIONS & EXPERIENCE:

We are looking for a professional MD with relevant medical training in Neuroscience (M.D/PhD a plus) as well as experience in Alzheimer. You will bring:

• 6 or more years (2 or more years for a Medical Director) of experience within Pharma Industry/Biotech, in 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
• Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred (relevant for Senior MD)
• 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

ABILITIES:

• 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.
• Good interpersonal, verbal communication and influencing skills; can influence without authority
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
• Clinical leadership: is regarded as an expert in the field, is highly respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results (for senior MD)
• Ability to travel globally (<30%)

Please note that depending on your experience and qualifications, we may offer one of these titles: Senior Medical Director/Medical Director

#ADMD

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.