Senior Clinical Scientist, Product Development Oncology (Morpheus Combinations Strategy)

United States of America, California, South San Francisco

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GENERAL POSITION SUMMARY/ PURPOSE:

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. The Senior Clinical Scientist participates in development of the Clinical Development (CD) strategy and plan and supports various deliverables for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Senior Clinical Scientists have primary responsibilities for supporting Medical Directors/Clinical Directors with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science input into study reporting. Senior Clinical Scientists are expected to perform their responsibilities with independence, acting as a CD leader. Senior Clinical Scientists have regular external interactions with cooperative groups, key opinion leaders (KOLs), external vendor partners supporting the work of CD, etc. They also participate in external interactions with health authorities (HAs).

PRIMARY DUTIES AND RESPONSIBILITIES:

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). 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
  • When assigned/appointed, can act as the Global Development Leader (GDL)
  • 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 core and sub-team processes, structures, systems, tools and other resources
  • As appropriate, coaches and guides less experienced Clinical Scientists
  • Where applicable, may manage or mentor one or more direct reports and is, in such instances, accountable for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures

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)
  • 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 serve as the CD representative for early development, post-marketing and/or diagnostics projects, and/or as CD representative to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
  • Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
  • Provides clinical science contributions into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
  • As assigned/applicable, develops the CD plan for assigned molecule(s)/indication(s) and/or other programs
  • Provides 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, develops and provides information and input to other groups regarding budget/resource requirements
  • necessary to implement and execute the CD plan
  • Participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients.

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
    • Conducts, or delegates, appropriate literature searches
    • Collaborates with clinical operations, other groups and Medical Directors/Clinical Directors 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 ensure consistent use of language and criteria across multiple Roche teams and projects (includes partner studies)
    • Writes, or oversees others in development of, 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.)
    • Oversees 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, or otherwise delegates development of clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (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
    • May provide additional support with site training, as needed, or requested; or, delegates these responsibilities to other Clinical Scientists
    • 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.; or, delegates these responsibilities to other Clinical Scientists
    • 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 Medical Directors/Clinical Directors, 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 and 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 other clinical documentation 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

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:

  • Bachelor’s Degree required (life sciences preferred)
  • Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.)
  • 6 or more years clinical trial experience (must demonstrate a minimum of 4 years clinical trial experience in pharma/biotech industry)
  • Data review experience
  • Experience working on a clinical team (or equivalent)
  • 2 or more years experience authoring aspects of a global clinical development plan or full clinical study protocol and publishing results of a clinical drug trial in a peer-reviewed journal
  • Strong relevant therapeutic area experience (2 or more years relevant experience)
  • Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects
  • Has successfully executed a Phase III program
  • Has considerable end of Phase II experience
  • Knowledge/understanding of Phase I & IV drug development is a plus
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., SCS, SCE, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • In-depth knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, MHRA 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
  • Regarded as a subject matter expert in clinical science development and the respective therapeutic area
  • Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
  • 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: highly 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, and 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
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams
  • Strong 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)
  • Ability to travel (<30%)

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