The Medical Communications Therapeutic Area Lead reports into the Global Medical Communications Leader, Global Medical Affairs. The Medical Communications Therapeutic Area Lead is an integral member of the Medical Communications team and is responsible for developing high-impact asset specific strategic Scientific Communications for assigned therapeutic area, including integrated Medical Communication Plan, which comprises but is not limited to the Scientific Communication Platform/Scientific Narrative, asset publication plan, congress strategy with HCP-directed educational symposia, HCP medical education, and Medical Affairs scientific booths. The ideal candidate will have at least 5 years of relevant hands-on experience with a minimum of 3 years directly in Medical Communications, either within the pharmaceutical industry or in a Scientific Communications agency.
The candidate will engage with cross-functional partners including Asset Team, Research & Discovery, Clinical Development, Commercial Development, Patient Advocacy and Medical Affairs, and oversee the conceptualizing, development and evolution of asset-specific strategic scientific narrative to be incorporated consistently across multiple platforms, including publications, congresses, and internal/external scientific educational resources. This role requires the ability to interpret scientific/clinical data, an understanding of the scientific research and healthcare landscape, an ability to interact and develop professional relationships with KOLs and external faculty and will help develop and communicate a compelling scientific story for assigned Spark products.
This person is accountable for writing/directing the development of slides and other scientific documents containing data from company-sponsored clinical and preclinical programs with minimal supervision. The scope also includes developing and executing a strategic publication plan, and strategic insight into the congress sponsorship plan in collaboration with the Medical Affairs Therapeutic Area Lead. He/she will work on cross-functional teams and manage external vendors and associated budgets to support the activities mentioned above.
% of Time
Job Function and Description
- Collaborate with R&D, Medical and Commercial partners on developing a Medical Communications plan that is supportive of strategic medical objectives.
- Develop Scientific Communications for an assigned therapeutic area, including integrated Medical Communication Plan which comprises but is not limited to the Scientific Communication Platform/Scientific Narrative.
- Develop congress strategy and execute medical education programs, scientific congress activities, and medical society outreach to educate the medical community and build advocacy for Spark development and launch activities.
- Establish a clear and viable strategy for the development of Scientiﬁc Publication Plans, aligned with overall asset strategic imperatives and objectives, to ensure ethical and transparent disclosure of data from Spark-sponsored clinical trials and another Spark-sponsored research.
- Promote consistent process for publication management activities, including leading publication planning meetings, and implement feedback into strategy to ensure publication plans are eﬀecive and eﬃcient.
- Ensure all assigned Spark-sponsored publications are developed according to Spark publication policy and good publication practice, including published guidelines (e.g., GPP3, ICMJE, CONSORT)
- Foster collaborative relationships with academic and clinical experts, publishers, medical associations, and other relevant stakeholder groups to advance awareness of Spark’s leadership in gene therapy in the scientiﬁc community.
- Lead external initiatives to foster trust and respect of Spark’s leadership in gene therapy amongst academic and medical publishing community.
- Liaise with external authors and internal contributors and manage publication speciﬁc meetings with medical writers and/or agencies as needed.
- Lead the appropriate review and approval of all Spark publications/projects, including abstracts, posters, oral presentations, and manuscripts from Spark-sponsored clinical trials and other Spark-sponsored research.
- Review deliverables to ensure publications and presentation meet quality control standards and are balanced in content.
- Establish strong working relationships with authors/external experts and with societies and congresses to support congress submissions.
Education and Experience Requirements
- Plan, track, and manage budget for assigned therapeutic area’s Med Comms projects.
- Develop forums and processes to communicate results and accomplishments to key stakeholders and to senior management.
Key Skills, Abilities, and Competencies
- PharmD or PhD with 5+ years of biopharmaceutical industry or medical communications agency experience, with a 3-year minimum of hands-on Med Comms experience leading the development and execution of industry sponsored symposia, scientific presentations and publications is required. Equivalent combination of education in related Life Sciences discipline and applicable job experience may be considered with minimum 8years of biopharmaceutical industry (and 3 years hands-on) experience operating at a high level.
- Scientific content development experience required across a variety of platforms, channels, and venues (e.g., symposia, videos, webinars, website content, infographics, posters, oral presentations, scientific communication platforms).
- Manuscript writing/editing, author/vendor management, and submission experience for scientﬁc/medical journals is required.
- Knowledge and experience in rare disease, especially hematology or lysosomal storage disorders is strongly desired.
- Certification as a Medical Publicatons Professional (CMPP) strongly preferred.
- Knowledge of FDA regulations regarding the dissemination of scientific content is required.
Complexity and Problem Solving
- Proficiency with Veeva Vault and Pubs Hub platforms.
- Excellent interpersonal skills and ability to build effective partnerships and work collaboratively with internal/external stakeholders in various functions, at various levels of seniority, and with a diversity of working styles.
- Experience with managing budgets including review of annual budget, tracking monthly projections, and accruals.
- Experience with developing and implementing new processes, SOPs and policies to facilitate Scientific and Professional Training, including identified areas for improvement and recommended changes as needed.
- Experience with congress planning activities around external scientific presentations.
- Excellent written and oral communication skills and the ability to take complex information and ideas and present it in aconcise way.
- Demonstrated understanding of the drug development process from drug discovery to preclinical development to clinical development to regulatory approval, strong scientific acumen and experience with compilation, presentation and review of scientific data.
- Excellent time management and organizational skills; ablity to prioritize tasks and work simultaneously on multiple projects.
- Strong knowledge of current good publication practices and guidelines and medical writing guidelines (e.g., GPP3, ICMJE, CONSORT).
- Experience managing external agencies.
- Proficiency with computer programs such as MS Word, Excel, and PowerPoint.
- Commitment to quality and continuous improvement.
Internal and External Contacts
- Proven experience in establishing strategic direction for teams/work-streams, and ability to achieve set objectives, ability to take educated risk, rise above technical expertise, demonstrating judgement, wisdom and understanding of impact.
- Ability to drive high performing, externally focused work-streams which emphasize teamwork, cooperation, personal accountability, and a commitment to quality; models Spark values and reinforces such behaviors at all levels in the organization.
- Demonstrated success in driving optimal business results in a complex corporate environment with multiple priorities and tight timelines.
- Ability to critically evaluate literature and interpret clinical data.
- Ability to work effectively, collaboratively and independently in a fast-paced, small-team environment that is growing and evolving. This position requires regular reprioritization of projects while adhering to timelines and achievement of deliverables.
- Ability to navigate the medical-legal review process and resolve comments appropriately and compliantly, while building working and trustful relationships with key stakeholders.
- Problem solving, negotiation and interpersonal skills, ability to work across diverse groups and senior leaders and with external key opinion leaders and researchers.
- Ability to innovate and present cutting-edge/creative solutions in the context of delivering scientific content and maintaining a high profile for the Medical Communications and Medical Affairs function by delivering exceptional value.
- Ability to critically evaluate scientific literature and evolving competitive landscape.
- High degree of emotional intelligence and experience with working in a matrix environment and with cross-functional teams.
- Superior project management skills, ability to track progress and adjust timelines as needed
- Ability to multi-task numerous projects at one time, prioritize projects based on Spark goals and objectives.
Other Job Requirements
- Medical Affairs Therapeutic Area Lead
- Medical Communications Lead-Scientific Content & Training
- Meeting Services Specialist, Medical Communications
- R&D Operations
- R&D leadership and other internal subject matter experts
- Development and Product Strategy
- Corporate Compliance
- Corporate Communication
- Third Party Scientific Communications Consultants and Companies
- External Scientific Conference Coordinator
- Travel: Up to 20%
- Physical Abilities: Ability to sit and stand for extended periods and utilize computer equipment.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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