Medical Director (Respiratory) (职位编号：70941644)

and is responsible for developing and executing the late development (Phase II

– IIIA) clinical strategies and plans that delivermedically-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 assignedmolecule(s)/indication(s).

The Opportunity:

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 assignedmolecule(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

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 internalpartners/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

Who you are:

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

required

● Understanding of 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 is preferred

Abilities:

● 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%)