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 Medical Director participates in development of the Clinical Development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned molecule(s)/indication(s). PD Medical Directors may have one or more direct reports. PD Medical Directors are expected to perform their responsibilities with more independence by comparison to Associate PD Medical Directors, including participating in health authority (HA) interactions with little to no supervision from their managers.
PRIMARY DUTIES AND RESPONSIBILITIES:
1. Cross-Functional Team Leadership & People Management
- Participates in and/or leads the relevant Clinical Science Team (CST)
- Can lead and/or otherwise represents CD in sub-teams (e.g. Study Management Teams) relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
- When assigned/appointed, can act as the Global Development Leader (GDL). Where assigned/appointed, expected to represent CD on core teams, e.g., Lifecycle Team (LCT)
- Accountable for training new CST members
- May also, as appropriate, support relevant sub-teams in assigning and training new team members
- As appropriate, participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources
- As needed or otherwise appropriate, assists with CD recruitment, training, and/or coaching of new or less experienced CD staff members
- Where applicable, may manage one or more direct reports and is, in such instances, responsible for hiring, training, developing and retaining talent on his/her staff. Consistently complies with all governing employment laws, regulations and company HR policies & procedures
2. 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)
- As appropriate, participates in 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 PD Medical Director:
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups
- May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing Phase I protocols and providing CD input into these
- Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input
- May also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
- Participates in CD strategy development and may present to various internal committees
- Develops and provides clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
- Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs:
o Seeks guidance from his/her manager, as and when needed, to ensure appropriate design and development of the CD plan
o Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs
o Guides CST and relevant sub-teams in developing all CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
o Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
- Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of Roche and patients. Escalates matters, as needed, in a timely manner to his/her manager or other internal partners/stakeholders
3. Clinical Development Plan Implementation
- Provides clinical oversight across all relevant studies and programs: o Leads and/or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions and communications
o Designs and develops clinical studies
o Collaborates with others in the development of the product safety profile o Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
o May participate in the identification and selection of appropriate external investigators and sites
o Guides and collaborates with others on patient registry design and development (including strategies for patient registry recruitment)
o Acts as CD lead in the development of study analytics and data management plans for each study
o Represents, alongside his/her manager or others, Roche in key investigator and other external presentations, meetings and other communications
o Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study Acts as a medical monitor for assigned studies
o Conducts ongoing reviews of medical/safety data o Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
o Collaborates with other groups to ensure timely and appropriate completion of interim study reporting
o Collaborates with clinical operations to close-out clinical studies, secure data and complete study reporting
o Accountable to ensure correct medical/scientific data interpretation for interim and final study reporting
o Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
o Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing labeling and packaging language, etc.
- Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche
- Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment
- Responsible to ensure that CD plans, objectives, and deliverables are consistently accomplished on-time and on-target
- Completes and/or leads other special projects, as and when assigned, or otherwise requested
- 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
- 4 or more years pharma/biotech industry experience OR is a recognized expert in the field
- 4 or more years experience with clinical trials. In-depth understanding of Phase II – III drug development
- Experience submitting an NDA/BLA to regulatory authorities in Europe and/or the U.S. is preferred
- Experience authoring aspects of a global clinical development plan or full clinical study protocol is preferred
- Experience publishing results of a clinical drug trial in a referred journal is preferred
- Knowledge/understanding of Phase I & IV drug development is a plus
- Academic/teaching background is a plus
- Experience working with 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
- Versed in 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
- Familiar with competitive activity in the field
- Previous people management experience is a plus ABILITIES:
- Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
- Outstanding attention-to-detail
- Clinical leadership: is regarded as an expert in his/her field, is respected by others, can effectively contribute to longer range drug development, and can lead cross-functional teams to successful results
- Business acumen: has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Can effectively contribute to development of disease strategies and plans
- Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
- Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
- Outstanding written communication skills
- Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
- Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
- Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
- 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
- Strong orientation to teamwork
- Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
- Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to successful outcomes)
- Ability to travel globally (<30%)
Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations