GCC Biologics Medical Manager
Job Description / Capsule
An internal and externally facing medical role that provides medical and clinical expertise in priority therapeutic/disease areas (usually 1 TA and 1-2 product) and builds AZ scientific leadership. Contributes with medical and clinical expertise in design of LCM and Brand Strategy. Takes leadership in creation and 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.
Executes the Medical Affairs strategy within area of specialisation, working closely with medical affairs colleagues.
Manages team of CSLs, developing in a role as leader & people manager.
May take responsibility as Nominated Signatory medical reviewer for activities and promotional materials. May lead Medical Information and Pharmacovigilance within a particular market.
1 - To establish AstraZeneca as a scientific leader through proactive, updated and effective Medical input
- Continuously acquire and update necessary scientific knowledge on therapeutic area and relevant compounds.
- Support Medical TA Lead at development of medical priorities for different brands within TA, and execution of medical plans activities.
- Collaborate with MSL to seek input from MSL insights for development of local medical plan .
- Develop and lead the delivery 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
- Ensure strategic alignment with Area/Regional & Global medical team
- Provide medical leadership on faculty and content development for medical programs 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.
- Participate as key member of brand team as strategic partner towards LCM actions including potential business development opportunities
- Together with MSLs maps OLs in relevant therapeutic area per country according to given criteria
2- To engage scientific leaders, professional bodies or societies to establish AZ as a scientific leader
- 30‐40% of time in field is 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 (prominent
- Liaise with local investigators and the External Sponsored Research organization to support research initiatives.
- Internally communicate competitive intelligence
3-Generate the medical evidence to support the brand strategies in priority TAs to meet 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
- ·Develop NIS or registry studies to address unmet medical needs.
- ·Support Clinical team to select appropriate investigators and sites optimising quality, delivery and cost
- ·Developing partnership with KOLs in order to develop their capabilities of conductingmedical studies
4- 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
- Supporttodevelopdrugvaluepackand communicateittoKeyDecisionMakers
- Supportmarketaccessactivitiesthatshape marketunderstandingofdisease,diagnosis and treatmentoptions
- Proactivecross-functionalcollaborationwith regulatory and other teams in drug registration in earlier and broader accessibilityalignedtothebrandstrategy
5- Defines and delivers training on Medical background of the product for various functions in an organization as required
- Provide effective Medical/clinical trainings (basicscienceanddiseaseknowledge,drug profile, clinical data) to internal colleagues in line with expressed needs of MSL manager and salesmanagers:
- Ensuresownknowledgeandknowledgeof team members of best practices and new relevant developments is up todate
6- Corporate responsibility, 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 AZ SOPs and GCP.
- Aligns with the values and vision of AZ
- Actively participate/encourage the development of the AZ culture
- Ensures compliance with AZ code of Ethics, EI policy Corporate Governance, Audits requirement, guidelines, codes, policies and procedures, discloses potential breach
- Provide guidance and act as a role model to support ethical decision making and proper prescription of medicines in brand activities.
- Ensures that company confidentiality is maintained (i.e. intellectual property, product, strategic and salary information)
- Ensures that all conducted activities are done in accordance with local legislation and corporate standards.
- Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.
- Can act as Nominated Signatory: Responsible for medical approval of promotional materials/activities and examination of non‐promotional media and scientific materials/activities for allocated brand(s).
7- Personal development
- Develop functional capability in the role
- Communicate, develop and role model AZ culture and AZ Values & Behaviors
- 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 programs, training, projects and meetings (where needed)
8- Leading a team of CSLs
- Manage the team of CSLs, and being responsible for coaching, performance and talent development. Provides, as expert, scientific and technical support on processes and projects within area of expertise
- Set ambitious goals for the employees and ensure their cooperation with other departments of the company to achieve better results
- Identify strengths and development needs, motivate and train subordinates to improve their performance effectiveness and develop functional and leadership competencies.
- Implement control measures to compare the actual results of the work performed with the goals and take appropriate action in case of deviations from the plan.
- Analyze and resolve possible difficulties for the effective work of the team. Create challenges and inspire team to increase productivity.
Education, Qualifications, Skills and Experience:
- Higher education in medicine/life sciences/pharmacy
- > 5 years of successful experience in Medical Affairs within a multinational pharmaceutical
- Basic people management/supervision experience
- Experience in strategic relationship and stakeholder management
- Strong decision making and problem solving skills
- High sense of urgency and commitment to excellence
- Strong clinical expertise and expertise/qualification in Business Management
- Qualified Medical Doctor in the required product or disease area
- MSc/PhD in a scientific discipline
- Good knowledge of international guidelines ICH/GCP
- Basic knowledge of GMP/GDP
- Experience of financial management, budget handling and financial control
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.