Senior/Group Medical Director and Global Head of Product Development, Nephrology & Rheumatology

United States of America, California, South San Francisco
Switzerland, Basel-City, Basel
United Kingdom, Hertfordshire, Welwyn

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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 – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Group Medical Director leads and oversees one or more Clinical Science Teams (CSTs) who are responsible for developing global Clinical Development (CD) strategies and plans and ensuring effective and efficient CD plan execution for one or more molecules/indications. PD Group Medical Directors guide development of and approve CD strategies, priorities, final interpretation and completion of clinical study results. PD Group Medical Directors interact with the highest levels of management and experts both internally and externally; serving as an internal consultant to Roche committees as well as representing the therapeutic area’s CD strategy, plans, objectives and interests to health authorities (HAs) and prominent thought leaders. PD Group Medical Directors are expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic area(s), including therapeutic area scientific strategies and plans.

Cross-Functional Team Leadership

  • Typically a standing member of the therapeutic area’s CD Leadership Team
  • Leads one or more CSTs
  • Represents CD for assigned portfolio at the highest management/expert levels inside and outside Roche; includes championing and sponsoring the work of his/her staff
  • When assigned/appointed, acts as the Global Development Leader (GDL). Where assigned/appointed, represents CD on core teams, e.g., Lifecycle Team (LCT)
  • Oversees one or more CSTs 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 (e.g., Study Management Teams), with which CSTs collaborate, to ensure on-time and on-target results
  • As needed, provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources

Staff Leadership & Development

  • Works with manager and peers to identify and ensure the appropriate infrastructure – clear roles and responsibilities, learning and development, technology, other tools, vendor partners and operating budgets
  • Assigns direct reports their projects and programs and guides direct reports in their assignment of projects and programs across their staff
  • Cascades strategic and other relevant goals and objectives as well as expense budgets to direct reports
  • Tracks departmental expenses 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
  • 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 Product Development objectives and activities
  • Consistently complies with all governing employment laws, regulations and company HR policies & procedures and ensures the same across his/her staff

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). 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) of assignment. Ensures the same across his/her staff
  • Educates others internally and externally on relevant 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). Has extensive interactions with these 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 at all levels and with various groups and functions, such as other groups in PD, research, business development, manufacturing, commercial operations, legal, etc.; providing ongoing leadership expertise and guidance on the assigned therapeutic area’s clinical strategy
  • Plays a leadership role in providing clinical science input into the relevant therapeutic area scientific strategy. Helps research and other PD groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals. As appropriate/needed, performs or delegates clinical assessments on relevant drug discovery projects
  • As needed, ensures his/her staff members support internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. Expected to provide expert leadership CD guidance, when needed, on Phase IIIB protocols
  • Consults to, and/or assigns staff members to consult to, pharma 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
  • Acts as an expert advisor and consultant to various internal committees, other Roche management and teams regarding CD strategies, priorities, implementation and the like
  • Leads global development of clinical science input into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP). 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:
    • Accountable to ensure strategic and operational alignment of CD plans with the relevant CD strategy, strategic and annual LCPs
    • Guides CSTs in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
    • Reviews budget and other resource requirements necessary to implement and execute CD plans. Provides leadership guidance and direction to ensure the most appropriate and optimal use of resources
    • Supports direct reports, as needed, to ensure they gain alignment with various internal partners/stakeholders on goals and resource needs. Includes guiding direct reports and other team leads
  • 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 Roche and patients. Accountable to ensure matters are escalated, when needed, in a timely manner to appropriate internal partners/stakeholders

Global Clinical Plan Development Implementation

  • 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
    • Reviews various items and activities and provides leadership guidance and direction to ensure successful execution and completion of clinical studies and other programs: study protocols, incorporation of crossfunctional strategies and input into programs, product safety profiles, etc.
    • Oversees development of clinical sections of investigator brochures, other external presentations, information and materials
    • As needed, guides others in the identification and selection of appropriate external investigators and sites
    • Guides others in patient registry design and development (including strategies for patient registry recruitment)
    • Advises direct reports and others on development of study analytics and data management plans for their key, large-scale studies
    • 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
    • Measures and monitors study progress against objectives and plans, including any variances. Proactively guides other team members on identifying, communicating and addressing any issues, challenges and potential strategies to resolve such
    • 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 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 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. Includes guiding others, as necessary, on development of labeling and packaging language, etc.
    • 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 Roche’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 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 Roche’s leadership position in CD
  • Consistently complies with, and ensures the same among relevant CST members, 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:

  • 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
  • 8 or more years’ experience with clinical trials
  • 2 or more years’ experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the U.S.
  • 4 or more years’ experience authoring global clinical development plans
  • 4 or more years’ experience publishing results of clinical drug trials in referred journals
  • In-depth understanding of Phase I – IV drug development Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
  • Strong academic/teaching background is strongly preferred
  • 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
  • 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

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
  • Clinical leadership: is recognized as a subject matter expert in his/her field (includes external recognition as an expert); able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective); has made significant contributions to an organization’s drug development (whether for Roche or another organization); has identified and created clinical development strategies that have led to label-enabling product definitions
  • Has demonstrated outstanding leadership of multiple development projects and teams
  • Proven abilities to plan and resource multiple development projects on short-, medium- and longer-term bases
  • Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
  • Strategic agility: has in-depth knowledge and broad experience in the pharma/biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
  • Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
  • Considerable comfort around all levels of management; has regularly demonstrated the managerial courage necessary to succeed at higher-levels within the organization
  • Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
  • Strong influencing skills; proven abilities to get things done without formal authority
  • Strong negotiation skills; is highly adept at identifying solutions that will meet the needs of all parties involved
  • Strong communication & presentation skills; exhibits professional maturity, confidence and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decisions
  • Strong conflict management skills; proactively minimizes situations where conflict may arise
  • Strong conflict resolution skills; proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties
  • Outstanding financial acumen: has a proven track record of achieving qualitative and quantitative results across multiple, often large- scale and complex clinical development projects
  • Ability to travel globally (<30%)