Lead Medical Director (Ophthalmology)

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

GENERAL POSITION SUMMARY/ PURPOSE:

Roches Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead 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). Lead Medical Directors may have one or more direct reports. Lead Medical Directors are expected to perform their responsibilities with more independence by comparison to Medical Directors including participating in health authority (HA) interactions with little to no supervision from their managers.

JOB DESCRIPTION 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

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 DevelopmentPlanning

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 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 Medical Affairs or publication studies. May review Medical Affairs 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 PlanImplementation

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

QUALIFICATIONS & EXPERIENCE:

M.D. with relevant medical experience in same/similar therapeutic area required

4 or more years pharma/biotech industry experience ORis a recognized expert in the field

4 or more years experience with clinical -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 peer reviewed 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 longerrange 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 wo rk through to successful outcomes)

Ability to travel globally (<30%)

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.