Advisor - Planning and Execution Manager- US Medical Affairs Immunology/Infectious Diseases
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position
The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes. Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.
Responsibilities:
The areas of major responsibility include, but are not limited to the following:
• Responsible for the day-to-day operations of the designated Medical teams.
o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules
o Co-leads and facilitates all medical team planning and decision-making
o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.
o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.
o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.
o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics
o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements
o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution
• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.
• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc.
• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution
• Conducts proactive risk assessment and change control for all assigned projects/programs
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities
Who You Are
Requirements: Unless stated as "preferred" or "a plus," all other criteria is required.
• Masters Degree in life sciences or related disciplines.
• Graduate-level degree in life sciences disciplines (Pharm.D., PhD in life sciences or MD), an MBA are a plus.
• A minimum of 10 years’ total work experience with at least 8 or more years’ relevant experience in the pharmaceutical/biotechnology or related industries.
• 4 or more years experience within drug development/commercialization project teams. Previous experience acting as a member of core/sub drug development/commercialization project teams is preferred
• 2 or more years related project management experience and a sustained track record of quantitative and qualitative success
• 4 or more years experience leading complex and heavily matrixed project teams or >2 years direct management experience
• Proven skills and proficiencies for large-scale budget development, management and administration
• Proficiencies with various project management systems, software/programs
• Relevant therapeutic area experience
• In-depth understanding of Phase IV and Medical Affairs programs. Understanding of and/or previous experience with Phase I - III drug development is required
• Some experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, [Integrated Summaries of Safety & Efficacy] competitor data, etc.)
• Comprehensive understanding of product and safety profiles
• Well-versed in medical aspects of FDA regulations
• Business travel, by air or car, is required for regular internal and external business meetings
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
