Genentech Principal Medical Director/Medical Science Director-Skin Tumor in South San Francisco, California
Principal Medical Director/Medical Science Director-Skin Tumor
South San Francisco
California, United States of America
Job ID: 202008-122543
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ROLE / JOB TITLE: Principal/Sr. Medical Director / Medical Science Director – Skin Portfolio
FUNCTION: US Medical Affairs (USMA)
REPORTS TO: Medical Partner LPT
LOCATION: South San Francisco
At USMA, we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all.
The Medical Director / Medical Science Director Skin Portfolio will report to the Medical Partner Lung/PanTumor (MP LPT), is a critical part of the cross-functional Skin leadership team (Squad*). MD/MSD Skin Portfolio is accountable for the development, delivery and execution of the medical strategy for the skin cancer portfolio. By bringing deep medical expertise, innovation, and critical thinking, they drive medical strategic planning and execution. The MD/MSD Skin Portfolio advocates the relevant medical perspective when creating Squad priorities and long-term strategies with an enterprise view and a customer-centric approach to drive medical progress. The individual in this role will maintain a comprehensive and in-depth understanding of the medical strategy and relevant clinical, market and access landscapes for the skin cancer therapeutic area. By putting patients and science at the center of all actions, they work in collaboration with the LPT MP to drive and guide medical strategy and tactics aimed at maximizing medical progress. They will play a critical role to establish and maintain professional relationships with key medical experts in their field and will oversee all aspects of medical product support including collaboration with the relevant stakeholders to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They understand and evaluate their team and organization’s opportunities and constraints and build capabilities with an enterprise mindset. They serve as the guardian for high standards of compliance, ethics and safety.
*A Squad is the cross-functional team of senior leaders responsible for a therapy area or set of products that is accountable for generating the 5-year vision, integrated customer plan, identifying 90-day priorities and enabling small, self-governing teams to design and develop the best solution for the patient/customers.
Own the medical value proposition of the Skin Portfolio, including pipeline & its contextualization in given therapeutic area(s) in order to implement medical strategies and tactics
Drive the synthesis and translation of complex scientific data/clinical situations into
strategy and solutions to optimize access and care for patients, with the ability to appreciate and navigate trade-offs within and beyond medical
Proactively bring feasible options for evidence generation (clinical and economic), medical communications and clinical and non-clinical customer engagement and insights with an understanding of the unmet medical needs (compliantly)
Ensure execution on evidence generation plan (clinical and economic), medical communications and clinical and non-clinical customer engagement that delivers on the shared 5-year vision, 90-day priorities and integrated customer plan
Ensure effective two-way communication between the Squad and the Medical Network (in order to socialize business/financial priorities to colleagues within USMA) so that they may ideate solutions, understand the rationale behind Squad decisions, provide guidance, and the context of activities across the network
Partner effectively across the Medical Network, within USMA internal functions and with global (REDs, PD, PDMA & GPS) colleagues to create and deliver options to support Squad short and long-term goals. Provide perspective so that teams avoid redundant efforts
Lead the formation and execution of high quality Phase IIIb/IV clinical trials and investigator-initiated research including study design, protocol writing, approval, implementation and conduct, clinical monitoring and study reports
Consistently engage with customers (patients, payers, healthcare professionals, professional societies, & cooperative groups) to understand their evolving medical needs and identify knowledge gaps & opportunities for collaboration, & scientific exchange through various channels to drive medical progress
Drive timely formation and execution of high quality Phase IIIb/IV clinical trials and investigator-initiated research including study design, protocol writing, approval, implementation and conduct, clinical monitoring, data interpretation and study reports
Maintain an in-depth understanding of relevant medical strategy in the context of the healthcare landscape & customers for the US & represent the US perspective in global conversations
Collaborate with key stakeholders, Medical Partners, and Chief Medical Partners to prioritize the most important work, meet enterprise resource needs, and ensure fluidity and flexibility of people across activities (initiatives, projects, WPTs, etc.)
Act with integrity as a guardian for high standards of compliance, ethics & safety
Ultimately accountable for the final assessment of benefit/risk and safety for patients, including medical monitor activities, product, clinical trial, and promotional material where patient benefit/risk assessment is needed; accountable for the training of customers and auxiliary staff in the medical/clinical use of our products (MDs only)
Ultimately accountable to provide strategic perspective based on a deep understanding of clinical decision-making to inform decisions about unmet medical needs and the impact of clinical data on clinical practice pattern (MDs only)
QUALIFICATIONS & EXPERIENCES:
Post-graduate degree required (e.g. MD, PhD, PharmD)
7-10 or more years of pharmaceutical / biotechnology industry experience – preferably in Medical Affairs or Product Development or is a recognized expert in the field
Scientific credibility and enterprise thinking on how medical affairs impacts the broader organization and ability to provide proactive solutions to complex enterprise needs
Superb collaboration, influencing, and communication (oral and written) skills in developing strong partnerships with cross-functional commercial, development, and global peers
Sophisticated understanding of the evolving regulatory, medical practice and economic environments impacting Roche / Genentech both globally and within the US; have a thorough understanding of US regulatory / FDA requirements
Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development ; experience in medical writing and the principles and techniques of data analysis, interpretation and clinical relevance
Demonstrated ability to build relationships with, and understand and identify the needs of patients, providers and payers
Substantive understanding and exposure to corporate legal and compliance groups, and be knowledgeable of issues related to, GCP, OIG and other guiding or controlling elements of our business
A successful track record of collaborating, coaching and influencing outcomes in complex organizations and projects
Embraces an agile mindset to develop necessary processes to get things done. Knows how to organize people and activities effectively to achieve impactful outcomes
Embraces new digital healthcare landscape to better serve patient needs
Business travel, by air or car, is required for regular internal and external business meetings
CMG Operating Principles
I put the patient first, always
I am obsessed with meeting customer needs
I act on behalf of the whole company, not just my team
I am inclusive
I have a growth mindset
I act with urgency
I am accountable
I radically simplify and prioritize for impact
I follow the science
I build our reputation
External Link: https://www.gene.com/careers/commercial-operating-principles
Who We Are
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.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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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.
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