Typically a standing member of the therapeutic area’s CD Leadership Team
Represents CD for assigned portfolio at the highest management/expert levels inside and outside Genentech; includes championing and sponsoring the work of his/her staff
When assigned/appointed, acts as Development Strategy Team Leader (DSTL). Where assigned/appointed, represents CD on core teams.
May be manager of DSTL/CSTLs
Oversees one or more DSTs for CD studies relevant to assigned molecule(s)/indication(s) and guides direct reports to, in turn, guide teams to ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
Ensures direct reports and their staff are actively and appropriately aligning with sub-teams, train new team members with which CSTs collaborate, to ensure on-time and on-target results
Guides relevant sub-teams in their decisions to assign and train new team members
Expected to provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources
May act as clinical representative at RRC for therapeutic area or relevant target/molecules
Works with others in the therapeutic area’s CD Leadership Team to identify and ensure the appropriate infrastructure – clear roles and responsibilities, learning and development, technology, other tools, vendor partners and operating budgets
Manages multiple Medical Directors along with Clinical Science Specialists, with oversight of multiple projects, and may serve as manager of other managers of Medical Directors
Expected to serve on the functional group leadership team and contribute to appropriate staffing and organization of functional group (e.g. ECD LT)
Assigns direct reports their projects and programs and guides direct reports in their assignment of projects and programs across his/her staff
Cascades strategic and other relevant goals and objectives as well as expense budgets to direct reports
Works with ECD business manager to tracks his/her group FTE use and projection, expense budgets to budgets to ensure compliance with agreed parameters
Leads recruitment, hiring and training for his/her staff member roles
Provides direct reports with ongoing coaching, development and leadership; includes holding regular staff and 1:1 meetings
Oversees staff members’ work to ensure on-time, on-target and within-budget results
Plays a leadership role in all formal and informal performance management and career development activities for his/her staff members, including oversight of training of managers to ensure effective management and career development, adequate staffing across accountable projects at all layers of his/her group
Leads succession planning for key positions within his/her staff; ensuring at all times a robust pipeline of talent to fill future openings
Actively participates in leadership and skill development programs for continued professional development
Initiates and develops cross-functional projects, programs or other initiatives that can carry broad and important impact to multiple gRED or PD objectives and activities
Consistently complies with all governing employment laws, regulations and company HR policies & procedures and ensures the same across his/her staff
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). Ensures the same across his/her staff
Provides CD leadership guidance and direction regarding competitive intelligence and/or other market/industry assessment activities and projects
Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s), pathway(s) of assignment. Ensures the same across his/her staff
Has considerable experience and skills in interpreting and translating non-clinical, pharmacological and pharmacodynamics data and how it applies to early phase trials to proof of concept studies. Ensures the same across his/her staff
Ability to interpret non-clinical toxicology studies and to apply appropriately in planning and designing first in human studies as well as development of a safety plan for early stage molecules
Deep knowledge base and experience in interpreting and analyzing scientific data with strong judgment skills in application and relevance in the clinical setting
Plays a leadership role in educating others internally and externally on relevant research and clinical developments as these may implicate the assigned therapeutic area’s CD strategies, plans and programs
Collaborates with a variety of internal and external partners and stakeholders, such as HAs, clinical investigators, clinicians, scientists and key opinion leaders (KOLs) as well as multidisciplinary internal groups, including other groups in gRED, research, business development, commercial operations, legal, etc.
Represents CD for the assigned portfolio to other internal Roche groups
Has extensive interactions with key external parties, subject matter experts and influencers. Supports his/her direct reports and/or other CD staff members in their communications and interactions with these external parties
Works across Roche/Genentech at all levels and with various groups and functions, such as other groups in gRED, PD, research, Medical Affairs, business development, manufacturing, commercial operations, legal, etc.; providing ongoing leadership expertise and guidance on the assigned therapeutic area’s clinical strategy
Expected to have a leadership role in providing clinical science input into the relevant therapeutic area scientific strategy. Helps research and other gRED or PD groups to ensure consistency of scientific and development strategies that are in line with late-development priorities with target label claims and corporate goals. As appropriate/needed, performs or delegates clinical assessments on relevant drug discovery projects
Ensures his/her staff members support internal partners in transitioning new drugs/indications into Phase III or publication studies. Expected to provide expert leadership and engage and align with late stage development (Pharma Development) to ensure successful alignment and transition for phase III implementation
Consults to, and/or assigns staff members to consult to, BD partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s). Serves on joint executive committees, which include other Roche functions as well as external partner personnel, and/or assigns such responsibilities to direct reports
Leads global CD strategy development for the assigned portfolio. Acts as a regular reviewer/presenter to various internal committees such as DRC
Acts as an expert advisor and consultant to various internal committees, other Genentech/Roche management and teams regarding CD strategies, priorities, implementation, data analyses and the like
Leads global development of clinical science input into annual MAP, DPAR, and PUB processes
Has oversight of DSTL’s and/or acts as molecule expert during transition to late stage development with assistance to late development in further clinical development, phase III trial design and other activities that will benefit from a molecule expert consultant
Acts as molecule/program expert during transition to late stage development with assistance to late development in further clinical development, phase III trial design and other activities that will benefit from a molecule expert consultant
Leads and directs all aspects of transitions as well as impact to relevant programs still in gRED
Acts as an expert advisor to others regarding CD strategic alignment with and implications for LCPs for the assigned portfolio
Oversees creation and implementation of global CD plans for all molecule(s)/indication(s) and/or other programs across the assigned portfolio:
As needed, or otherwise appropriate, supports direct reports and/or other team members in their communications with HAs
Accountable to ensure his/her team members ethically, effectively and professionally represent the interests of Genentech/Roche and patients. Accountable to ensure matters are escalated, when needed, in a timely manner to appropriate internal partners/stakeholders
Accountable for the design, execution and medical/scientific data interpretation of global clinical studies and programs across the assigned portfolio:
Manages across multiple, often large-scale and highly complex projects
Provides guidance to direct reports in the strategy, design and implementation of clinical studies and other programs for their roles
As needed, guides others in the identification and selection of appropriate external investigators and sites
Provides leadership guidance and direction to ensure successful execution of cross-functional strategies and input into programs, product safety profiles, etc.
Advises direct reports and others on development of dose finding study analytics for pharmacokinetic and pharmacodynamics profiles, criteria for identifying target exposures or appropriate thresholds for dose selection and data management plans
Advises direct reports and others on development of study analytics and data management plans for proof of concept studies
Advises direct reports and others on criteria and risk analysis for LIP decisions as it relates to design and data from proof of concept studies and as appropriate parallel development of companion diagnostics and its implications
Reviews and approves clinical components of presentations for clinical trial investigator and other relevant meetings
As needed, supports direct reports in conducting investigator or other external presentations, meetings and other communications
Provides ongoing guidance to direct reports, cross-functional teams, internal committees and company executives regarding the overall strategy, implementation and prioritization of CD activities across the assigned portfolio
Regularly reviews medical/safety data and evaluate translatability to non-clinical pharmacology and toxicology data
Develops or directs criteria for dose selection and endpoints that may serve for proof of concept studies
Identifies and establishes phase III go criteria in consultation with the appropriate PDO representatives
Measures and monitors study progress against objectives and plans, including any variances and changes in risks to program. Proactively guides other team members on identifying, communicating and addressing any issues, challenges and potential strategies to resolve such
Proactively communicates with research teams to inform changes in risk and value for relevant targets
Reviews and approves various interim study reporting prior to further dissemination
Serves as a resource for issue management and resolution. Anticipates issues and helps prevent and/or resolve these
Oversees or directs clinical study, database and study reporting completion. Approves final study reporting prior to further dissemination
Accountable to ensure correct medical/scientific data interpretation for interim and final study reporting
Guides direct reports in their assimilation and translation of safety and efficacy data for regulatory submissions
Oversees or directs clinical science input for completion and submission of regulatory filings and other regulatory documentation. Advises direct reports and other team members in their development of clinical science information and input into regulatory submissions and other regulatory processes
Keeps partners and stakeholders abreast of developments relative to the work of CD and the assigned portfolio and ensures same approach is consistently taken across his/her staff
As needed, advises direct reports and other team members regarding communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials used to communicate Genentech’s clinical view and position on clinical development plans and study results for molecules/indications across the assigned portfolio
Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes regularly acting as an expert participant and contributor on advisory boards and other relevant external forums representing Genentech/Roche
Drives ongoing data generation. Plays a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs
Accountable to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target
Leads other special projects. Expected to proactively identify opportunities to continuously improve CD processes and operations and Genentech/Roche’s leadership position in CD
Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, Genentech/Roche Standard Operating Procedures (SOPs) and other guidelines
M.D. with relevant medical experience in same/similar therapeutic area required
10 or more years pharma/biotech industry experience OR is a recognized expert in the field. A minimum of 4 years industry experience is preferred
4 or more years experience managing medical/clinical staff with proven track record of successful management, mentoring and career development
8 or more years experience with clinical trials
Extensive experience submitting an IND/IMPD/CTA to regulatory authorities in Europe and/or the U.S.
4 or more years experience authoring global clinical development plans or 4 or more years experience publishing results of clinical drug trials in referred journals
In-depth understanding of Phase I – II drug development Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.) Phase III experience is preferred
Experience in basic research, data interpretation in area of relevance, Ph.D. degree preferred
Strong academic/teaching background is strongly preferred
Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance
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, NICE and other relevant guidelines and regulations
In-depth understanding of competitive activity in the field
Current or past leadership roles in major scientific and advocacy organizations and standard-setting bodies is preferred
Relocation benefits are available for this job posting.
