Job Detail

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/programs. PD f 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.

JOB DESCRIPTION – 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 for assigned portfolio at the highest management/expert levels inside and outside Roche; includes championing and sponsoring the work of his/her staff


• 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


• 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

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


• 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

3. 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


• 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 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 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:
  
  
  
  • Accountable to ensure strategic and operational alignment of CD plans with the relevant CD strategy, Disease Area Strategy and 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 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
  
  

QUALIFICATIONS & EXPERIENCE:

• Board-certified 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 (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

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%)


• Drug Development Expertise


• Scientific Expertise


• Medical Expertise


• Disease Expertise


• Leadership


• Strategic Agility


• Innovator and Competitive mindset


• Creative Mindset


• Collaboration and Communication


• Portfolio/Enterprise View

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