Global Development Lead/Senior, Associate Group or Group Medical Director for "Mosunetuzumab" Non-Hodgkin Lymphoma

United States of America, California, South San Francisco

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Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase IB – III) clinical strategies and plans that deliver medically differentiated therapies that provide meaningful improvement to patients. The PD Global Development Leader (GDL) is a core member of the Lifecycle Team Leadership Team (LCT LT) and is responsible for overseeing and developing global Clinical Development (CD) molecule and disease strategies and ensuring effective and efficient execution for one or more molecules, indications and programs.   The scope of this role also includes therapeutic area scientific strategies and plans, including acting as a key collaborative partner with gRED, pRED, Chugai, and partner companies.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Cross Functional Team Leadership

  • A key member of the Lifecycle Team’s LT (GDL, LCL and IBL), representing Product Development (PD) 

  • Leads cross-functional, fit-for-purpose team(s) with a focus on product development, molecule or disease strategy (Development Working Groups, Clinical Science Team CST, as appropriate and assigned by the LCT LT)

  • Represents PD/CD on cross-functional strategic workstreams and initiatives as well as with internal (REDs, PD functions) and external (Business Development, Partnering, Scientific and Medical Societies, Therapeutic Area Experts, Regulatory Authorities) interactions

  • Oversees multiple Clinical Development Plans (CDPs), disease strategies, molecules and/or indications, as well as associated clinical trial programs and studies. Guides direct reports to ensure cross-functional integration, coordination, and alignment to enable effective and efficient CDP execution

2. Staff Leadership and 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

  • Cascades strategic and other relevant goals and objectives as well as expense budgets to direct reports

  • Provides direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins, and 1:1 meetings

  • Initiates and develops cross-functional projects, programs or other initiatives that can carry broad and important impact to multiple Product Development objectives and activities

3. Global Clinical Development Leadership

  • 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

  • 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 clinical scientific strategy, as well as into relevant cross-functional and enterprise-wide plans, strategies and initiatives. Helps Research and 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

  • 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 interactions with internal and external fit-for-purpose Advisory Forums and groups, in close collaboration with other LCT LT members.

  • 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

QUALIFICATIONS & EXPERIENCE

  • We are looking for a professional Board-certified M.D. with relevant medical experience in same/similar therapeutic area required and 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. You will bring:

  • 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 (exact number of years depending on level)

  • 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.)

  • 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

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

  • 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 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 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 skills with stakeholder management in a large organization