Director, Medical Affairs

For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech manufactures and commercializes multiple biotechnology products that have helped patients suffering from serious diseases and conditions, including breast cancer, colorectal cancer, non-Hodgkin's lymphoma, lung cancer, rheumatoid arthritis, cystic fibrosis and allergic asthma. The company is the leading provider of anti-tumor therapeutics in the United States.


Our continued growth has created an opportunity for a Director in our South San Francisco headquarters. Please take this opportunity to learn about Genentech, where the creativity and openness of an academic environment meet the rigorous dedication of industry-leading professionals focused on improving and extending people’s lives.


Responsibilities:
This position is an integral part of Genentech’s protocol development process. The candidate will recruit medical writers and staff, as well as develop the new Development Writing group which will provide key support in the development of clinical study protocols. The candidate and the medical writers will work with clinical scientists, biostatisticians, PK/PD scientists, clinical operations personnel and data managers to create high quality protocols that meet both project and corporate goals. The candidate and this group will also work closely with Development Editing to increase the efficiency of the review and approval processes for protocols and protocol amendments.
REQUIREMENTS
A B.S./B.A. in Life Sciences, Liberal Arts or an equivalent field is required. A minimum of five years of experience in the biotechnology or pharmaceutical industry as a manager is a must. A minimum of 8–10 years of editing or writing experience, preferably with regulatory or scientific documentation, is required. Comprehensive understanding of the drug development process is essential. The ability to influence, lead and collaborate with others is a must. Excellent organizational skills are required. The candidate must possess the ability to resolve problems, address complex issues on a cross-functional level and make policy decisions. The ability to assign staff to meet aggressive deadlines while maintaining high-quality deliverables is essential. Project management experience and excellent interpersonal and communication skills are required. Proficiency in Microsoft Word is a must.


Genentech offers one of the most comprehensive benefits packages in the industry. Join a company that attracts, retains and rewards talented and committed employees. Our culture emphasizes working hard, collaborating and sharing rewards. For immediate consideration, please visit www.gene.com/careers and reference Req. #1000013409. Genentech is an equal opportunity employer.