Medical Director, Autism Digital Therapy

South San Francisco
California, United States of America


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The Position

The Medical Director role within Product Development, Neuroscience will be reporting to the Global Development Leader for Autism Digital Therapy Program.

Main Responsibilities:

  • Ability to work closely with the product development team (including software engineers) to guide product development towards a product that will be ready for a registrational clinical trial.
  • Responds to, or guides others in their responses to, questions from other internal and external parties regarding assigned studies and programs
  • Conducts or oversees others in conducting clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medical inquiries
  • Plays a leadership role in safety meetings; identifies and escalates any potential safety events
  • Participates in senior-level discussions and reviews of clinical study reporting documents
  • Ensures appropriate items are included in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments; or, delegates these responsibilities to other Clinical Scientists  
  • As appropriate, responds to HA inquiries
  • Works closely with PD Medical Directors/Clinical Development Physicians, clinical operations and other groups to close-out clinical studies,  secure data and complete study reporting
  • Plays a leadership role in the development and implementation of communications strategies to support existing and concluded studies.  Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
  • Delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities.  Includes presenting at advisory boards and other relevant external forums representing Roche
  • Writes or oversees others in developing abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials as well as coordinating reviews with internal partners and stakeholders.  Ensures timely coordination of submissions to scientific meetings and/or other appropriate venues or groups
  • Plays a leadership role in completion and submission of regulatory filings and other regulatory documentation.  Writes sections of HA meeting packages and assists in the development and review of clinical documents required for regulatory submissions and other regulatory processes  
  • Works with others to drive ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs for the relevant therapeutic area of assignment
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested  
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

QUALIFICATIONS & EXPERIENCE:

  • M.D. with relevant medical experience in same/similar therapeutic area required
  • 4 or more years pharma/biotech industry experience OR is a recognized expert in the field
  • 4 or more years’ experience with clinical trials. In-depth understanding of Phase II – III drug development
  • Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
  • Experience publishing results of a clinical drug trial in a referred journal is preferred
  • Knowledge/understanding of Phase I & IV drug development is a plus
  • 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.)
  • Comprehensive understanding of product and safety profiles
  • 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
  • Familiar with competitive activity in the field
  • Previous people management experience is a plus

ABILITIES

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Outstanding attention-to-detail
  • Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to long range drug development, and can lead cross-functional teams to successful results
  • Business acumen: has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Can effectively contribute to development of disease strategies and plans
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Outstanding written communication skills
  • Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
  • Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Strong orientation to teamwork
  • Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to successful outcomes)

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.


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