EMEA Medical Affairs Director (EMAD), Ibrutinib

Job description

OVERVIEW OF THE ROLE:

Job Title: EMEA Medical Affairs Director (EMAD), ibrutinib
Location: EMEA based in Central European Country
Reporting to: EMEA Therapeutic Area Lead – Haematology (ETAL)

This newly created role is to have oversight of the upcoming indications for ibrutinib (DLBCL, FL, cGVHD). The post holder will work closely with the other EMAD for ibrutinib (CLL, WM, MCL), and have flexibility to cover additional indications for ibrutinib as business needs dictate

There will be no line management responsibilities on first taking up the position but is a future possibility pending upcoming business need.

The EMAD will drive the activities as described in the job profile below.

EMEA MEDICAL DIRECTOR – JOB PROFILE

To develop the EMEA Medical Strategy and the EMEA Medical Affairs Product Plan (MAP Plan) for a specific product or group of products in line with Global strategy and in alignment with the Integrated Brand Value Team (IBVT) strategy, taking into account both weighted needs of the EMEA countries and feedback from the external scientific communities / thought leaders.

To contribute to the development of the Therapeutic Area Medical Strategy in collaboration with the EMADs of the Therapeutic Area and under the leadership of the EMEA Therapeutic Area Leader (ETAL), and in line with the Global Strategy and in alignment with the Integrated Brand Value Team (IBVT) strategy.

To represent EMEA MAF for specific product or group of products at IBVT, which includes shaping the brand strategy.

To lead the EMEA Medical Affairs Product (EMAP) team and the functional network, and to ensure effective communications between the local, regional and global groups. To act as the Medical Affairs expert and drive a unified EMEA Medical voice.

To represent the unified EMEA MAF voice at the Global Medical Affairs Team.

To drive the implementation of the activities outlined in the EMEA Medical Affairs Product strategies and Plan across EMEA in close cooperation with other EMEA functions, including; EMEA Medical Affairs Program Lead (EMPL), Scientific Knowledge Management (SKM), Medical Education Scientific Relations (MESR), Regulatory Affairs, Strategic Marketing, Health Economics Market Access and Reimbursement (HEMAR).

To oversee the EMEA Medical Affairs budget for pan-EMEA activities for those assigned product(s) for which the EMAD is accountable

MAIN ACTIVITIES/TASKS:
EMEA Medical Affairs Product Leadership
To act as the EMEA MA expert and drive the strategy for a specific product or group of products:
· articulate the consolidated medical voice for EMEA
· represent EMEA voice at regional and global teams (IBVT, GMAT, lifecycle teams)
· develop and maintain detailed knowledge in products, market trends, competitor activities etc.
· build up / maintain network with external thought leaders to ensure clear understanding of external thinking and ensure external input into product strategies and tactics.
To provide expertise to EMEA functions (Medical, Commercial, HEMAR, Regulatory Affairs etc.) and functional network in the countries.
To represent EMEA MA for specific product or group of product at IBVT, which includes shaping the brand strategy and providing input into the development of the EMEA plan ensuring alignment with the IBVT strategy.
To oversee the EMEA Medical Affairs budget for pan-EMEA activities for assigned product(s) for which EMAD is accountable.
To lead the EMAP team: EMPLs, MESR, SKM and the Medical Affairs functional network to deliver EMEA MA Strategy and Plan:
· Work with the EMAP Team to gather input for the EMEA Medical Affairs Product Plan(s) for designated product(s) according to the EMAP Team charter.
· Draft the EMEA Medical Affairs Product Plan for allocated product(s) and drive the review and approval process with the EMAP team, EMEA Therapeutic Area Team (ETAT), the EMEA Medical Affairs Leadership Team (EMALT) and IBVT.
· Work with the EMAP Team to proactively identify and provide medical input into opportunities for new indications or lifecycle extensions for allocated product(s)
· Work with the EMAP Team to develop approaches to support successful market access for allocated product(s) in partnership with HEMAR, the CDT (Compound Development Team) and lifecycle management teams.
· Leverage product(s) expertise, medical and market insight to shape and direct implementation of product(s) strategies and plans
· Work with the EMAP Team and Medical Affairs functional network to drive the implementation of the Strategy and Plan
· Ensure effective and regular communications between Global, Regional and local MA teams, including regular communications to help minimise duplication of clinical, advocacy and access programs across countries, and facilitate co-ordination between EMEA Medical Affairs, CDT, Strategic Marketing, HEMAR and individual countries.
Being a member of the GMAT:
· To represent the unified EMEA voice
· To shape Global MA Strategy for the product
· To input into the CDT, including input into phase II/ III designs, and country and site selection
· To input into the Global Clinical Program with the aim to reach alignment and avoid duplication or conflicting clinical projects
· To provide input on the breakthrough research in line with the unmet medical / social needs in EMEA region
· To provide input into phase I designs
· To provide input into publication plans
· To provide input into Medical Educations plan / activities in the EMEA region
Accountable for line managing EMEA Medical advisors:
· Allocation of responsibilities for product ownership and other activities
· Objective setting
· Performance management and performance evaluation
· Coaching and feedback outside of the formal performance management processes
· Ensure that appropriate training is undertaken in core EMAP Team and Medical Affairs, functional skills, Good Clinical Practice (GCP) and required SOPs etc..
External Relationships
To maintain and leverage relationships with investigators, EMEA thought leaders and patient groups to gain input into the development of the product strategy, to specific protocols, and to services ensuring high-quality disease care.

Product Safety and Regulatory Requirements
As per the J&J guidance and SOPs:
· Manage Product-related medical safety issues and provide input to the Pharmacovigilance & Medical Compliance department and Safety Management Teams (SMTs).
· Work with Regulatory Affairs & Product Issue Management Team to coordinate and manage Product-related issues and support major quality incidents / recalls throughout Janssen EMEA
· Escalate issues and enquiries to ETAL responsible for specific products as appropriate
Provide requested information as specified in the Call For Information (CFI) distributed by GMS, during the initiation of Periodic Safety Update Reports (PSUR),
As appropriate responsible, as Study Responsible Physician, for the writing and the quality of the Study Specific Safety Summary for pan-EMEA studies, per ASR guidance and the J&J template. Also responsible for ensuring that ASR reporting to the Competent Authorities and IECs for IMPs with existing ASR schedules is compliant with the procedures and SOPs.
Provide clinical input to CCDS or SmPC update process and where appropriate ensure development and approval of clinical overview.

Study Planning and Execution
Ensure that all EMEA MA protocols (pan EMEA and single country) are in alignment with, and support, the medical strategy:
· Work with the EMAP team to define pan-EMEA study concepts
· Develop scientific content for pan-EMEA protocols and give guidance to the design of local studies as appropriate
· Accountable for having pan-EMEA study concept and protocols approved according to defined timelines, with the support of the appropriate EMPL, including HEMAR activities, collecting patient level data, translational research activities
· Accountable for the regional review of study concept (ReCAP process) for local studies
· For pan-EMEA studies, act as Study Responsible Physician (SRP) or oversee the SRP and ensure they follow EMEA Medical Affairs Study Planning and Execution SOPs. Align country selection with IBVT strategy
· Work with the EMPL and GCO to support them in the timely execution of pan- EMEA studies in accordance with current SOPs and within budget
· Provide medical oversight for the identification and feasibility analysis of countries and investigational sites
· Provide scientific input into the generation of the ethics/regulatory submission documents and provide responses to ethics committee/regulatory authority questions, to facilitate regulatory / ethics approval
· Provide medical input into the trial CRF development / database set-up
· Conduct a medical review of, and approve the clinically-related study materials (e.g. patient alert cards)
· Provide medical content input to the preparation of study specific training materials for monitors, investigators etc.
· Provide strategic direction and guidance to the development of the Statistical Analysis Plan, top line statistical analysis results and final statistical analysis package
· Accountable for Final Study Report for pan-EMEA studies
· Coordinate the review of the clinical study report with scientific committees , work to finalise the report and gain internal approval to publish
· Work to ensure that the Clinical Study is published and in accordance with the applicable publication SOP / procedures.
Publications
· Develop and disseminate an EMEA MA publication strategy (as part of the MA Strategy and Plan for allocated product(s), in alignment with the Global publication strategy).
· Ensure that J&J guidelines for publication of studies are followed, and that all MA studies (local and EMEA) are published in accordance with J&J policy. Ensure EMEA messages relating to allocated product(s) (including core medical education materials, abstracts, medical information materials, marketing materials etc.) accurately reflect scientific data.
Medical Education
· Work with the designated MESR (Medical Education Scientific Relations) to integrate and align medical education plans and budgets with the EMEA MA Strategy and Plan for allocated product(s)
· For pan-EMEA Medical Education activities, agree with the EMEA MESR on Medical Education programs concept, review the program proposals and final program outline (e.g. ensure final agenda is aligned with company strategy and latest knowledge on company products) and review scientific Medical Education materials in collaboration with SKM (e.g. review data accuracy on J&J products)
· Approval of Pan-EMEA Medical Education activities
Scientific Knowledge Management (SKM)
· Review and approve the content of EMEA Core Medical Information Responses (EMEA CMIRs) once drafted by the SKM (Scientific Knowledge Management) Product Specialists and Virtual Teams
· Work with designated EMEA SKM Product Specialist(s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
· Act as expert resource, providing input to responses to complex medical information enquiries
External communication team
Review and approve the content of EMEA communications drafted by the communication team

Promotional and market research Materials
· Medical review and approval of marketing materials (e.g. detail aids)
· Medical review and approval of market research materials

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Desired profile

Qualifications :

ESSENTIAL KNOWLEDGE & SKILLS:
·  In-depth knowledge with at least one product within TA including main competitors
·  Excellent knowledge of the TA in general with a good knowledge of all products within TA
·  In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis)
·  Good knowledge of EU CTD and GCP requirements
·  Good knowledge of study execution, Global Medical Safety and regulatory affairs
·  Sound knowledge of study publication processes and publications within the TA
·  Highly customer and market place focused with an awareness of the importance of business results
·  Innovative with the ability to coordinate and drive a complex and changing environment
·  Ability to work effectively in a matrix environment
·  Strong leadership skills, capable of driving a multi-cultural, virtual team
·  Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
·  Awareness of, and adherence to, Johnson & Johnson Credo values
EXPERIENCE:
Higher scientific or Medical degree essential
2+ year experience in clinical medicine in an area relevant to the TA
5 + year industry / business experience with a minimum of 2 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
1 – 3 year project management, team leader or functional line management experience


SPECIAL REQUIREMENTS:
Fluency in English language required
Fluency in additional EMEA languages an advantage
Able to accommodate substantial travel (c40%)

JOB LOCATION:
The role is EMEA based in a central European country and is likely to involve extensive EMEA and International travel.
The role holder can be based in his / her current country of residence as long as easy access to travel / transportation and local hosting is available at a Janssen office

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