South San Francisco
California, United States of America
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 (LCT) 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/programs. PD GDLs guide the development of molecules and programs, approve Clinical Development Plans (CDPs) and priorities, and lead the design and final interpretation and completion of clinical studies. PD GDLs are members of the PD Clinical Science organization, have a medical (M.D.) background or · Advanced Clinical/Science Degree (e.g., PharmD, PhD, MSN, MPH, etc.) and can manage a team of PD Clinical Medical Directors and Clinical Scientists.
PD GDLs interact with the highest levels of management and serve as scientific, medical, product development, and strategic experts both internally and externally. The GDLs serve as internal consultants for Roche committees as well as represent the therapeutic area’s CD strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders worldwide. PD GDLs are expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic/disease area(s), including therapeutic area scientific strategies and plans, including acting as a key collaborative partner with gRED, pRED, Chugai, and partner companies. The TA and Franchise Heads may delegate approval of protocols, ICFs, IBs, and PBRERs to the GDLs depending upon the GDL’s level of scientific and technical expertise.
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:
Cross-Functional Team Leadership
A key member of the Lifecycle Team’s Triad (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 (Global Development Team GDT, Clinical Science Team CST, as appropriate and assigned by the LCT triad)
As member of the LCT Triad, provides input and leadership regarding key decisions for molecules, Disease Areas, and Therapeutic Areas, including decisions regarding prioritization of activities.
Ensures direct reports and their staff are actively and appropriately aligning with sub-teams (e.g., Study Management Teams), 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 managers and peers to identify and ensure the appropriate infrastructure – clear roles and responsibilities, learning and development, technology, other tools, vendor partners and operating budgets
Where applicable, may participate in the negotiation with and commissioning of external vendor partners to support certain elements of the therapeutic area’s CD function
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
Leads recruitment, hiring and training for his/her staff member roles
Provides direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins, 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
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 Leadership
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
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
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
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 and Medical Affairs 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 interactions with internal and external fit-for-purpose Advisory Forums and groups, in close collaboration with other LCT Triad 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:
Global Clinical Plan Development Implementation
Accountable for the design, execution and medical/scientific data interpretation of global clinical studies and other evidence generation programs across the assigned portfolio.
Guides others in patient registry design and development (including strategies for patient registry recruitment).
Drives and integrates ongoing evidence/data generation, including clinical trials, Medical Affairs studies, Real World Evidence (RWE), Patient-Centered Outcomes Research (PCOR) and other types of evidence. Plays a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs
Manages a team
QUALIFICATIONS & EXPERIENCE:
Board-certified M.D. with relevant medical experience in same/similar therapeutic area required or · Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, etc.).
10+ years pharma/biotech industry experience OR is a recognized expert in the field. A minimum of 4 years industry experience is preferred (exact number of years depending on level)
4 or more years experience managing medical/clinical staff (exact number of years depending on level)
8 or more years experience with clinical trials (exact number of years depending on level)
2 or more years experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the U.S. (exact number of years depending on level)
4 or more years experience authoring global clinical development plans (exact number of years depending on level)
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.)
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
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%)
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