EMEA Medical Affairs Director Hematology

Description: Johnson & Johnson is currently seeking an EMEA Medical Affairs Director Hematology to join our EMEA Strategy & Operations organisation.

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Responsibilities:

To develop the EMEA Medical Strategy and the EMEA Medical Affairs Product Plan (MAP Plan) for Ciltacabtagene Autoleucel and Talquetamab 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 represent EMEA MAF which includes shaping the brand strategy.

To lead the functional networks as required, and to ensure effective communications between the key 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 GMAT.

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 (EMEA Medical Affairs Program Lead [EMPL], Scientific Knowledge Management [SKM], Medical Education Scientific Relations [MESR], Regulatory Affairs, Strategic Marketing, Health Economics)

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

CORE ACTIVITIES:

EMEA Medical Affairs Product Leadership

• 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
• provide expertise to EMEA functions (Medical, Commercial, Health Economics, Regulatory Affairs etc.) and functional network in the countries
• Oversee the EMEA Medical Affairs budget for pan-EMEA activities for assigned product(s) for which EMAD is accountable.
• To represent EMEA MAF for specific product or group of products, which includes shaping the brand strategy and providing input into the development of the EMEA plan ensuring alignment with the strategy
• Lead the EMEA Medical Affairs Product Team (EMAP team: EMEA Medical Programme Lead (EMPLs), MESR (Medical Education Scientific Relations, SKM (Scientific Knowledge Management) 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 Health Economics, 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
• Being a member of the GMAT: and CDTs
  • To represent the unified EMEA voice,
  • To shape global MA Strategy,
  • To ensure input in Compound Development Team (CDT) , including input into phase II/ III designs, and country and site selection and on life cycle management strategy
  • To provide input into publications plan
  • and into Medical Educations plan/activities into EMEA soil

Accountable for line managing EMEA Medical advisor:

• 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 (e.g. internal seminars) in core MAP Team, Medical Affairs, functional skills, Good Clinical Practice (GCP) and required SOPs is undertaken

External Relationships

Maintain and leverage relationships with investigators, EMEA thought leaders and patient groups to gain input into the development of the product strategy and to specific protocols

As core MAP Team lead, ensure regular communications between EMEA and MA Functional Network to help minimise duplication of advocacy and access programmes across countries, and facilitate co-ordination between EMEA Medical Affairs, CDT, Strategic Marketing, Health Economics and individual countries

Product Safety and Regulatory Requirements

As per the J&J guidance and SOPs:

• Manage Product-related medical safety issues and provide input to the PV EMEA Pharmacovigilance & Medical Compliance, Janssen EMEA Medical Affairs 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),
• 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 SOP’s.
• 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 MAP 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 designed in partnership with MAO and approved in accordance with global and regional governance according to defined timelines, with the support of the appropriate EMPL
  • Accountable for the regional review of study concept (ReCAP process) for local studies
  • Review and approve single country interventional protocols according to EMEA PRAP process
  • Get input from GDO/GCO
• For pan-EMEA studies, act as Study Responsible Physician/Scientist (SRP/SRS) or oversee the SRS 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, and within budget, execution of pan- EMEA studies in accordance with current SOPs
• 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 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 role
• 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 EMEA MA 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 MESRL (Medical Education Scientific Relations Lead) 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 MESRL 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 MAP Team(s) designated EMEA SKM (Scientific Knowledge Management 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

Promotional and market research Materials

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

Other Activities As Required

• Provide input to EMEA business development initiatives for allocated product(s) when requested
• Partner with the late lifecycle management group to provide proactive medical input for lifecycle extension opportunities as appropriate

ACCOUNTABILITIES:

• EMEA Medical Affairs Strategy and Plan
• Line Management of Medical Advisors
• Product budget for pan-EMEA MAF activities
• Study Specific Summaries of pan-EMEA studies for Annual Safety Reports
• Design, approval and sign off on Protocols for pan-EMEA studies
• Final Study Report for EMEA MA Studies
• Product EMEA MA Publication Strategy
• Review and approval of product EMEA Medical Education Programs and scientific materials
• Sign off on EMEA Core Medical Information Responses (CMIRs)
• Medical review and approval of market research and promotional materials

#HemaOnco

Qualifications:

ESSENTIAL KNOWLEDGE & SKILLS:

• Good knowledge of the hemato-oncology, in particularly multiple myeloma, is advantageous.
• 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
• Experience in evidence generation and publication strategy.
• 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 medical qualification (eg MD/PhD/PharmD) essential
• 2+ years’ experience in clinical medicine in an area relevant to hematology
• 5 + years 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 years project management, team leader or functional line management experience desirable

SPECIAL REQUIREMENTS:

• Fluency in English language required
• Fluency in additional EMEA languages an advantage
• Able to accommodate substantial travel

CORE COMPETENCIES REQUIRED FOR THIS ROLE:

Must demonstrate a high level of expertise in each of the following core competencies – the competencies are ranked in order of importance for this role:

• People management
• Customer & Market Insight
• Adaptability and flexibility
• Product/ Therapeutic Area Awareness
• Publications and Scientific Presentations
• Product Development Expertise
• Organisation and Project Management

Job location

• The role is EMEA based and is likely to involve extensive EMEA and International travel (25%-50%)
• The role holder will be expected to 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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.