18 days old

Senior Medical Science Director, Respiratory & Immunology

Roche
South San Francisco, CA

Key Accountabilities

In this position, you will primarily be accountable for consistently, and effectively:

  • Making important contributions to pre-launch, launch and post-marketing medical strategies and plans; participating in and contributing to therapeutic area planning and reviews
  • Demonstrating increasing independence, working with less guidance and supervision, in strategizing, designing and executing clinical trials, other clinical studies and investigations, and other medical programs and related activities
  • Participating in and contributing medical affairs insights into Lifecycle Management and Lifecycle Plans, 3-year and 1-year brand and tactical plans, and other appropriate activities for assigned molecules/products
  • When assigned, acting as the Medical Team Leader for cross-functional medical affairs teams and/or as the lead Medical Affairs representative on cross-functional medical affairs teams or other core or sub-teams
  • Accomplishing the majority of your work with minimal supervision
  • Acting as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
  • Compliantly engaging in partnerships with thought leaders and other external stakeholders to gain insights on medical affairs plans and activities
  • Managing your projects and other deliverables to ensure goals and objectives will be met or exceeded

Example Responsibilities

In this position, you will:

  • Medical Plan Development:

When assigned to the Medical Team for assigned molecules/products:

Contribute to or organize the work of assigned team(s) to include strategy development, implementation and oversight of execution

Guide assigned teams throughout all intervals to ensure strategies, plans, goals, objectives and targets will be met or exceeded

Play a lead role in providing medical input into assigned disease area's commercial strategy

Develop the Medical Plan for assigned molecules/products

Act as a standing or ad hoc member of development and/or commercial core and/or sub-teams as well as Global Medical Affairs teams

Represent U.S. Medical Affairs to ensure alignment of the medical strategy with the Lifecycle Plan and other business strategies and plans for each assigned molecule/product

  • Clinical Studies:

Work with MSLs and others to develop strategies, plans and programs for Phase IV clinical trials and other post-marketing medical investigations or studies

Where assigned, participate in development of designs and protocols for clinical trials, other studies and investigations

Where assigned, support others in developing clinical components of presentations at meetings with clinical trial investigators, study site clinical research staff, etc.

Support MSLs and others in implementing trials, other studies and investigations in the field

Where applicable, guide others on patient registry design, development and implementation. Includes strategies and plans for registry recruitment and retention

Contribute and provide medical input on relevant medical communications, publications, health economics and outcomes research, data management, documentation and database requirements to support clinical trials, studies and investigations

Measure study progress, monitor variances and to proactively identify any issues or challenges. Develop, recommend and execute strategies to effectively resolve issues

Work with others to close-out trials, other studies and investigations and complete internal reporting of status and results

  • Communication/Other:

Lead exploratory data analyses to uncover additional medical opportunities for relevant molecules/products

Support others in the interpretation and publication of analyses of real-world data

Work with thought leaders in the publication of exploratory data analyses and analyses of real-world data

Work with MSLs and medical communication specialist to develop responsive medical communication documents and statements

Act as a key contributor to or lead for peer review sessions and, when appropriate, a frequent reviewer in internal review committees

Maintain the highest standards and levels of scientific, clinical and technical expertise in assigned therapeutic area(s)

Required Experience/Knowledge

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following knowledge, skills and abilities to be considered as a suitable applicant. Please note that except where specified as âœpreferred,â or as a âœplus,â all points listed below are considered minimum requirements. Years of experience listed below can be substituted with equivalent, relevant competency levels.

  • Advanced Clinical/Science Degree (e.g., PhD, MD, PharmD)

Knowledge

  • 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: including scientific/clinical, safety, legal/regulatory, medical writing, and analytics.
  • Understanding of product and safety profiles
  • Versed in medical aspects of FDA regulations
  • Relevant therapeutic area knowledge

Experience

  • 2-4 or more years' pharmaceutical/biotechnology industry experience or is a recognized expert in the field (with a minimum of 2 years research experience relevant to the pharmaceutical/biotechnology industry)
  • Relevant therapeutic area experience in respiratory/pulmonology/allergy/inflammation (as typically measured by 2 or more years' experience)
  •  Experience in the principles and techniques of data analysis, interpretation and clinical relevance
  • Conference and peer-reviewed manuscript publication experience

Skills/Abilities

  • Proven track record of meeting or exceeding objectives and goals
  • Clinical leadership: subject matter expert in his/her field or potential to become an expert; able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective)
  • Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics
  • Strong project and process management skills: proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and tasks through to successful conclusion
  • Demonstrable abilities to work independently and, when called upon, to oversee the work of others, in strategizing, designing and executing medical plans, clinical research programs, communication programs, and publications. 
  • Strong communication & presentation skills
  • Good negotiation skills
  • Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams
  • Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Strong customer orientation/focus

Business travel, by air or car, is required for regular internal and external business meetings

Posted: 2018-12-28 Expires: 2019-01-27

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Senior Medical Science Director, Respiratory & Immunology

Roche
South San Francisco, CA

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