Clinical Scientist Entrectinib

Salary depends on experience
Posted on 06/22/18
San Francisco, CA
8 - 10 years experience
Pharmaceuticals & Biotech
Salary depends on experience
Posted on 06/22/18

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Leadership & Management

  • Participates in the relevant Clinical Science Team (CST)
  • Represents CD in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s), except the Global Development Team (GDT). As needed and appropriate, addresses CD study or other program-specific questions; provides updates; delivers presentations; etc. May act as the lead CD representative on sub-teams
  • As requested, or otherwise appropriate, trains new CST members
  • May also, as appropriate, support relevant sub-teams in assigning and training new team members
  • As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools and other resources
  • As appropriate, coaches and guides less experienced Clinical Scientists
  • Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures

2. Global Clinical Development Planning

  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
  • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
  • May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these
  • Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input into these
  • Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
  • Participates, alongside PD Medical Directors/Clinical Development Physicians, in the development of clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
  • Develops the CD plan with the PD Medical Director/Clinical Development Physician for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to create the CD plan. May also delegate such research and analysis to less experienced Clinical Scientists
  • Supports PD Medical Directors/Clinical Development Physicians by providing additional guidance and direction to CSTs and other relevant teams in developing all CD plan components (e.g. analytics/data strategy, KOL development, publications strategy, etc.)
  • Where applicable and assigned, supports PD Medical Directors/Clinical Development Physicians in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
  • Supports PD Medical Directors/Clinical Development Physicians in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients

3. Clinical Development Plan Implementation

Provides strategic clinical science support for assigned studies and programs:

  • Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
  • Develops innovative clinical study designs for review and discussion with PD Medical Directors/Clinical Development Physicians and/or Global Development Team Leaders (GDTLs)
  • Conducts appropriate literature searches
  • Collaborates with clinical operations, other groups and PD Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc. Helps coordinate consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)
  • Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Roche groups (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
  • Helps coordinate the successful completion of documents with other groups
  • As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
  • Collaborates with clinical operations to develop and implement the overall data quality plan
  • Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with PD Medical Directors/Clinical Development Physicians (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
  • Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs
  • As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings
  • Provides additional support with site training, as needed, or requested
  • Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
  • Responds to questions from other internal and external parties regarding assigned studies and programs
  • Collaborates with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with PD Medical Directors/Clinical Development Physicians, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
  • Participates in safety meetings and tracks, analyzes and reports any potential safety events
  • Reviews, analyzes and discusses clinical study reporting documents with PD Medical Directors/Clinical Development Physicians and various other groups
  • Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
  • Assists PD Medical Directors/Clinical Development Physicians in responding to HA inquiries
  • Supports PD Medical Directors/Clinical Development Physicians in preparing for internal/external meetings and presentations
  • 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
  • Participates 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
  • May also deliver 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 and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups
  • Supports PD Medical Directors/Clinical Development Physicians, regulatory and other internal partners/stakeholders with completion and submission of regulatory filings and other regulatory documentation. Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
  • Works with PD Medical Directors/Clinical Development Physicians 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

SELECTION CRITERIA:

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as

“preferred,” or as a “plus,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

  • Bachelors Degree required (life sciences preferred)
  • Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
  • 8 or more years clinical trial experience (must demonstrate a minimum of 4 years clinical trial experience in pharma/biotech industry)
  • Data listing review experience
  • Experience working on a clinical team (or equivalent)
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol
  • Experience publishing results of a clinical drug trial in a referred journal
  • Strong relevant therapeutic area experience (typically demonstrable with 2 or more years relevant experience)
  • Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects
  • Broad experience in 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
  • Well-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
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
  • Previous people management experience is a plus

Job ID: 3597024028

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