Candidate will lead a team of direct and indirect reports, which means he/she will manage other people managers. Candidate will oversee a team of medical directors and their teams who are responsible for creating, executing and monitoring medical strategies, plans, programs and other tactics, including data generation and management, thought leader interactions, sponsored trials, supported trials, registries, exploratory data analysis, publications, other medical communications, medical education, medical meetings and events, etc. for all pre-launch, launch and marketed Genentech products in the assigned portfolio.
Candidate will provide guidance regarding medical strategies, multiple plans and prioritization for the assigned portfolio.Medical Directors (MDs) can be assigned responsibilities as general MDs for particular product(s), or specific responsibilities for Scientific Collaborations, Patient Registries or other specialty Medical Affairs assignments. All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business. Key AccountabilitiesIn this position, candidate will be primarily accountable for consistently, effectively:
Developing the medical vision and strategy for molecules/products across the assigned portfolio
Overseeing multiple, often large-scale post-marketing trials, studies, investigations, other projects and programs for the assigned portfolio to ensure all activities are completed on time, to high standards and within budget
Contributing to the long-term vision, strategy, plans and results for the overall U.S. Medical Affairs organization and the assigned therapeutic area(s)
Proactively identifying and leading cross-functional projects and initiatives that carry broad impact across Medical Affairs
Representing Medical Affairs on multidisciplinary Genentech and global Roche teams
Acting as an expert advisor to internal committees, management and teams regarding strategic medical issues and lifecycle planning
Providing expert leadership guidance and input Lifecycle Management, Lifecycle Plans, 3-year and 1-year brand/tactical plans for all molecules/products in the assigned portfolio
Acting as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
Compliantly developing and cultivating long-term strategic partnerships with thought leaders and other external stakeholders
Inspiring your team, recruiting, developing and retaining talent and ensuring a strong succession plan for key positions
Hire, develop and oversee the work of direct and indirect reports
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate- and longer-term
Act as part of the assigned USMA Medical Unit Leadership Team and play a key role in cross-functional planning and decision making
Develop/lead organizational design, resource requirements, compensation, expense budgets, immediate-, medium- and long term capacity for the assigned Medical Affairs function and team
Provide vision and strategic direction to your team
Advise senior leadership, direct reports and others internally and externally on strategic medical issues and considerations
Act as a key contributor to or lead for peer review sessions; includes acting as a frequent reviewer in internal review/ decision making committees
Oversee and guide development of post-marketing medical strategies and Medical Plans
Provide critical, strategic insights and recommendations across multiple medical projects and other activities
Work with team and therapeutic counterparts in Genentech and global groups to align Medical Plans, goals and objectives at the affiliate, regional and global levels
Medical Affairs Management/Operations
Assign team members as Medical Team Leads and as standing or ad hoc members of Product Development Medical Affairs teams, other core and sub-teams.
Ensure appropriate and adequate representation across teams relevant to assigned portfolio Where assigned, act as a standing member of the relevant Product Development Medical Affairs Team
Where assigned, serve on Joint Executive committees, which include other Genentech and/or global Roche partner functions as well as external collaborator personnel
Act as expert participant and contributor on advisory boards and presenter at other external forums
Provide medical affairs support for Phase III clinical trials
Consult to Genentech Business Development on relevant acquisitions, joint ventures or other strategic partnerships
Develop and deliver presentations, both internally and externally, to convey the medical perspective and provide updates on activities relevant to assigned portfolio or therapeutic area
Attend and contribute at major scientific and medical conferences
Provide medical affairs input into competitive intelligence activities and projects
Provide expert review of published scientific and clinical literature
Oversee medical programs and tactics across multiple projects. Direct others in developing and executing medical strategies, trials, other studies and investigations, communication, education, health economics and outcomes research and publication activities over a range of products within the assigned portfolio
Oversee and guide design, execution and data interpretation of post-marketing clinical trials and other post-marketing medical investigations or studies
Provide ongoing guidance on the overall strategy and prioritization of medical plan activities across the assigned portfolio
Maintain the highest standards and levels of scientific, clinical and technical expertise in assigned therapeutic area(s)
Have extensive interactions with prominent thought leaders and other relevant external parties
MD (Board Certified MD within therapeutic area is preferred)
In-depth knowledge of PV, ICH-GCP and other relevant standards and guidelines
Strong knowledge of the overall drug development process (Phase IV drug development experience; Phase I - III drug development is a plus)
Proven expertise with a wide range of data/information: scientific/clinical, safety, legal/regulatory, medical writing, analytics, etc.
Comprehensive understanding of product and safety profiles
Well-versed in medical aspects of FDA regulations
Relevant therapeutic area knowledge
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.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.