Associate / Group Medical Director, Breast Oncology

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 II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Associate PD Group Medical Director leads and oversees one or more Clinical Science Teams (CSTs) who are responsible for developing Clinical Development (CD) strategies and plans and ensuring effective and efficient CD plan execution for assigned molecules/indications. Associate PD Group Medical Directors guide development of and approve CD strategies, priorities, final interpretation and completion of clinical study results. Associate PD Group Medical Directors participate in the development of, and make contributions to, in the assigned therapeutic area’s scientific and clinical strategies and plans. Associate PD Group Medical Directors may have global or key market responsibilities. JOB

DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Leadership

  • May lead one or more CSTs
  • PDC on core teams, e.g., Lifecycle Team (LCT)
  • Oversees one or more CSTs for PDC 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 CDP 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

2. 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
  • Where applicable, may participate in the negotiation with and commissioning of external vendor partners to support certain elements of the therapeutic area’s 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
  • 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

3. Global Clinical Development Planning

  • Keeps abreast of internal and external developments, trends and other dynamics relevant to the work of PDC 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 PDC leadership guidance and direction regarding competitive intelligence and/or other market/industry assessment activities and projects
  • Keeps abreast of 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 on relevant clinical developments as these may implicate the assigned therapeutic area’s PDC 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). May have interactions with these external parties, subject matter experts, and influencers.
  • 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 and clinical development guidance, when needed, on Phase IIIb protocols
  • May lead global PDC strategy development for the assigned portfolio. May act as a regular reviewer/presenter for various internal committees
  • Acts as an expert advisor and consultant to various internal committees and other Roche management and teams regarding PDC strategies, priorities, and implementation
  • May lead 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 PDC strategic alignment with and implications for LCPs for the assigned portfolio
  • Oversees creation and implementation of global PDC plans for all molecule(s)/indication(s) and/or other programs across the assigned portfolio:
  • Accountable to ensure strategic and operational alignment of PDC plans with the relevant PDC strategy, strategic and annual LCPs ​
  • Guides CSTs in developing all PDC plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
  • Reviews budget and other resource requirements necessary to implement and execute CDP.. 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

4. Global Clinical Plan Development Implementation

  • Manages across multiple, sometimes 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 cross- functional 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) o Advises direct reports and others on development of study analytics and data management plans for their key, studies
  • Reviews clinical components of presentations for clinical trial investigator and other relevant meetings o As needed, supports direct reports in conducting investigator or other external presentations, meetings and other communications
  • Reviews various interim study reporting results 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. Reviews final study results prior to further dissemination
  • Responsible for ensuring correct medical/scientific data interpretation for interim and final study reporting
  • Keeps partners and stakeholders abreast of developments relative to the work of PDC 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.
  • Drives ongoing data generation.
  • Accountable to ensure that PDC plans, objectives, and deliverables are consistently accomplished on time and on target

QUALIFICATIONS & EXPERIENCE:

  • M.D. with relevant medical experience in same/similar therapeutic area required
  • 8 or more years pharma/biotech industry experience OR is a recognized expert in the field. A minimum of 2 years industry experience is preferred
  • 2 or more years experience managing medical/clinical staff
  • 6 or more years experience with clinical trials. Expert knowledge of Phase II – III drug development
  • Experience submitting an NDA/BLA 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
  • Knowledge/understanding of Phase I & IV drug development is strongly preferred
  • 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 proven abilities to effectively lead and manage multiple staff members, projects and teams to successful conclusion. Has strong cross-functional team leadership skills and has consistently excelled as a cross-functional project team leader
  • Can build vision and strategy and lead others in the accomplishment of this
  • 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
  • Outstanding business acumen; knows the industry, key competitors and other marketplace factors/dynamics
  • Proven track record of effective decision-making; makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
  • Comfort around all levels of management; has demonstrated managerial courage in past positions and responsibilities
  • 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
  • Outstanding orientation to team work: works collaboratively, effectively and efficiently with others internally and externally