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 II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Associate PD Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient CD plan execution for the assigned molecule(s)/indication(s). Associate PD Medical Directors participate in health authority (HA) interactions with supervision from more experienced PD Medical Directors.
1. Cross-Functional Team Membership
• Participates in the relevant Clinical Science Team (CST)
• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
• As requested, supports the CST lead and overall team with training new CST members
• May also, as appropriate, support relevant sub-teams in training new team members
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
• 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, regulatory, business development, commercial operations, legal, etc.
• Participates in CD strategy development
• Supports other CST members with development of clinical science information for inclusion into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development 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
• As assigned, 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 development of the CD plan for assigned molecule(s)/indication(s) and/or other programs to include gathering and analyzing data and information necessary to create the CD plan, working with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.) and working 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
• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of Roche and patients
3. Clinical Development Plan Implementation
Provides clinical support across all relevant studies and programs:
• Participates in ongoing CST and relevant sub-team meetings, except Development Working Group (DWG), other interactions and communications
• Designs and develops clinical studies for review and discussion with other CST members
• May collaborate with others in the development of the product safety profile
• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials
• May participate in the identification and selection of appropriate external investigators and sites
• May assist others with patient registry design and development (including strategies for patient registry recruitment)
• Collaborates with others in development of study analytics and data management plans
• Participates in investigator and other external presentations, meetings and other communications
• May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions
• Acts as a medical monitor for assigned studies
• Conducts ongoing reviews of medical/safety data
• 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
• Supports, as needed, completion of interim study reporting
• Works closely with other CST members and clinical operations to close-out clinical studies, secure data and complete study reporting
• Reviews study data to ensure correct medical/scientific data interpretation for interim and final study reporting
• Participates 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
• Works with other CST members, 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 label and packaging language, etc.
• Develops presentations for other CST members to deliver to convey the CD perspective and provide updates on strategies, plans and other activities
• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment
• Completes other special projects, as and when assigned, or otherwise requested
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
QUALIFICATIONS & EXPERIENCE:
• M.D. with relevant medical experience in same/similar therapeutic area required
• 2 or more years pharma/biotech industry experience OR is a recognized expert in the field
• 2 or more years experience with clinical trials across Phase II – III drug development
• 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.)
• Experience developing 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
• Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche Values
• Outstanding attention-to-detail
• Has working knowledge of the multi-disciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
• Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
• Good interpersonal, verbal communication and influencing skills; can influence without authority
• Strong written communication skills
• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally
• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy
• Works well within teams and is effective in collaborating with others internally and externally
• Ability to travel globally (<30%)
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