30/07 Manish
Operations Head at Renovative Consultants

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Therapy Area Specialist Lead - MBBS + PhD - Pharma (5-15 yrs)

Bangalore Job Code: 3983

Specific Background Requirement: A professional with education-background of MBBS followed by a PhD, with 5 to 15 years of experience working in pharmaceutical industry with a MNC.

Job Description / Capsule :

An internal and externally facing medical role that provides medical and clinical expertise in priority therapeutic/disease areas and builds Company's scientific leadership. Leads the development of medical plans for the TA/ Brands. Participates and contributes to development of LCM and Brand Strategy and aligning medical plans to the brand strategy. Takes leadership in implementation of Medical Plan/ activities in alignment with Brand strategy. Ensures that the Medical Activities meet the needs of patients and customers. Engages Opinion Leaders in ESRs, scientific exchange meetings and advisory board meetings. Defines and delivers training on Medical background of the product or various functions in an organization. May take responsibility as Nominated Signatory or medical reviewer for activities and promotional materials.

Objective Critical actions Measures : 

(Quantitative - Qualitative - Attitudinal) : 

To establish the company as a scientific leader through proactive, updated and effective Medical input and Communication - Continuously acquire and update necessary scientific knowledge on therapeutic area and relevant compounds (including competitor products).

- Develop and implement the local medical plan to address unmet medical needs in priority disease areas and ensure alignment with the brand plan.

- Collaborate with MSL to seek input from MSL insights for development of local medical plan.

- Develop and implement pre-launch medical plan/activities for new products at least 2 years prior to the planned launch in the country to address key clinical and scientific challenges

- Provide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needs

- To ensure that the Medical Information provided both to external and internal customers is timely, relevant, accurate and scientifically balanced

- Provide local medical expertise to local area/regional brand teams

- Provide medical input to phase 1 to 4 study protocols, study feasibility and support operational delivery

- Provide Medical expertise to support PSP market research, PASS and ESRO. Quantity

- Completion of the medical academy modules for the TA

- Number of reactive ESRO discussions

- Delivery of approved prelaunch medical plan in line with local brand strategy

- Implementation of the prelaunch medical plan.

Quality :

- Proactive update of medical knowledge in the internal meeting

- An approved Medical plan that is fully aligned with the Brand strategy.

- Medical information should meet defined markets standards - time and, quality standards.

To engage science leaders, professional bodies / societies to establish the organisation as a scientific leader in the TA - 20-30% of time in field may be required for engagement with the highest priority HCPs and key external stakeholders- engagement

- Share emerging data with HCPs, discussing all aspects of the data in a scientific, objective and balanced way

- Disseminate results of studies completed to medical community by translating their clinical values and incorporating into business strategies

- Attend relevant scientific congresses and HCP meetings to gather new knowledge on AZ compounds, competitor information and therapeutic area

- Conduct professional scientific communication or presentation (become chairperson/presenter when necessary) with key opinion leaders

- Liaise with local investigators and the External Sponsored Research organization to support research initiatives.

- Internally communicate competitive intelligence Quantity

- Timeliness and actual number of achievements: P2P, 1:1 interaction, advisory board, publication, CME,

responses to queries versus plan

- Market preparation of new launch product and/or pipeline among OLs.

Quality : 

- customer feedback post events/symposia

Generate medical evidence to support the brand strategies in priority TAs to meet local unmet medical needs

- Idea generation of the company sponsored clinical research

- Oversight and accountability of the operation of the studies

- Initiate research discussions, for example NIS, with customers to develop studies that will fulfil global and local business strategies. (May as part of the review team conduct initial assessment of any ISS proposals)Participate as key member of brand team as strategic partner towards LCM actions including potential business development opportunities

- Develop NIS or registry studies to address unmet medical needs.

- Developing partnership with OLs in order to develop their capabilities of conducting medical studies

- Partner with local SMM team to support country participating in global studies - Number of discussion - NIS/IIS Proposals

- Oversight and all accountability of the operation of the studies, i.e. Milestones, quality and capacity of the study

- Timely publications of studies completed as per the publication plan

- Initiatives with investigators to develop capabilities in conducting medical studies

Provide medical expertise to shape regulatory environment to achieve rapid and high quality market access of AZ products including new registration, new product evaluation and life cycle - Support develop drug value pack and communicate it to Key Decision Makers

- Support market access activities that shape market understanding of disease, diagnosis and treatment options

- Proactive cross functional collaboration with regulatory and other teams in drug registration in earlier and broader accessibility aligned to the brand strategy

- Present at SEC meetings as and when required

Quantity

- Number of communications to KDMs versus plan

- Meet the critical project timeline

Quality

- Feedback from cross functional team

Defines and delivers comprehensive training on Medical background of the product for various functions in the organization as required - Provide effective Medical/clinical trainings (basic science and disease knowledge, drug profile, clinical data) to internal colleagues in line with expressed needs of MSL manager and sales managers:

- Ensures own knowledge and knowledge of team members of best practices and new relevant developments is up to date Quantity

- Percent completion of trainings conducted versus plan as per the business needs versus plan

Quality

- Feedback from participants ; facilitator effectiveness average more than 4 points

- MSL and MR competency in terms of disease knowledge, drug profile and clinical data (through MSL Accreditation)

Governance and ensuring overall adherence to processes and regulation [include but not limit to patient safety, clinical trials, promotional activities, etc - ]


 - Accountable for ensuring Promotional Compliance : Provide medical input to the creation, development and agreement of promotional material and ensure all material is in line with internal SOPs and meets IFPMA code

- If appropriate to market, Ensure that Pharmacovigilance activities meet internal SOP and local regulations

- Ensure clinical studies are carried out in accordance with A the company's SOPs and cGCP. Support Clinical team to select appropriate investigators and sites optimising quality, delivery and commercial benefit

- Aligns with the values and vision of the company

- Actively participate/encourage the development of the company culture

- Ensures compliance with the company code of conduct, Corporate Governance, Audits requirement, guidelines, codes, policies and procedures

- Ensures that company confidentiality is maintained (i.e. intellectual property, product, strategic and salary information)

- Discloses potential breach of codes or conducts - Display behaviours consistent with the AZ vision and values (those with line report, their team members demonstrates the same)

- Feedback from others; climate survey

- No non-compliance issues raised with local and global policies and procedures

- No valid complaints from competitors against marketing practice

- No breach of confidentiality. All disclosures are investigated and resolved

- No critical finding in relevant internal or regulatory authority audits

Personal development

- Develop functional capability in the role

- Communicate, develop and role model AZ culture and AZ Values & Behaviours

- Develop individual and team accountability

- Identify areas for self-development and discuss developmental needs with line manager using the 70-20-10 principle (experiential learning, coaching/networking/relationship-based learning and class room training)

- Attend & actively participate in learning programmes, training, projects and meetings (where needed) - 100% completion of training as required on Medical Academy

- Feedback on congress report/highlights shared with cross-functional team as planned - completed feedback templates

- Having a personal development plan and completes identified development activities as planned

Feedback from key stakeholders (optional)

Typical People Management Responsibility (direct / indirect reports)

1-5 Approximate number of people managed in total (all levels) : 1

Matrix Manager - (projects/dotted line)

0

Manager of a team

0

Grandfather (manager of a manager)

What is the global remit?

(how many countries will the role operate in?) Operates in : 1

Remit which covers all AstraZeneca countries

Education, Qualifications, Skills and Experience :

Essential Desirable : 

- A medical degree with specialization, or appropriate clinical experience, in the required product or disease area

- Medical/Scientific knowledge in the responsible disease area

- Experience of Medical Affairs function within the pharmaceutical industry

- Fluency in English is required & Excellent presentation skills

- An ability to travel

- Experience in relationship and stakeholder management

- Team management experience

- Knowledge of the latest technical and regulatory developments - Understanding of multiple aspects within Medical Affairs

- Project management experience

- Interest in a long-term career in the pharmaceutical industry

Key Relationships to reach solutions

Internal (to the company or team) External (to the company)

- Senior Management within Brand or Disease area

- Medical Affairs Function

- Regulatory affairs

- Market access

- Marketing

- R&D team

- Compliance Team - Service Providers

- Regulatory bodies

- Payor/reimbursement agency

- Other local and regional stakeholders

- Healthcare professionals (esp. KOLs)

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