Director Medical Writing Jobs in Pennsylvania

INTRODUCTION

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
• Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary

The Senior Director, Global Medical Affairs, Neuromuscular is responsible for development and delivery of the Medical Affairs plan and strategies for AskBio's Neuromuscular programs. This individual will be the Senior Medical Affairs leader on Neuromuscular Integrated Product Team (IPT). The responsibilities will include but are not limited to: Medical Communications and Publications, Patient Advocacy, Field medical strategy, Continuing Medical Education, Health-Economics Outcomes Research (HEOR), Integrated evidence generation, Medical Advisory Boards and Medical Review of Materials.

KOL engagement plan in collaboration with clinical operations and clinical development. This plan should start with KOL mapping based on the needs of the early development program (thinking through the lens of how the KOLs will potentially inform guidelines and clinical practice). The KOL engagement plan should have metrics attached to it and actionable insights generated monthly.

Job Responsibilities

• Be a functional leader in the medical team with matrixed responsibility to IPT leadership; serve as co-leader of the IPT branding sub-team
• Partner with Pipeline Commercial, Clinical Development, Clinical Operations, Corporate Communications, R&D, and other functions to develop and implement global Medical Affairs strategies for the Neuromuscular programs while maintaining the highest level of industry compliance, patient centricity and scientific standards
• Collaborate with clinical study teams to enable recruitment and retention of clinical studies
• Execute and support Medical Affairs activities including key opinion leader engagement, congress planning, advisory boards, publication planning, generation of standard response letters, post marketing data generation and HEOR analysis
• Establish relationships and facilitate interactions with thought leaders and advocacy partners (professional and patient organizations) including scientific collaborations, speaker training, advisory boards, and regional/national/international conferences
• Develop KOL engagement plan in collaboration with clinical operations and clinical development (incl. KOL mapping based on the needs of the early development program).
• Develop congress strategy, including tactical execution about strategic planning of KOL meetings, impact of sessions, competitive intelligence and collection of insights feeding into clinical development program and generation of post-congress debrief reports.
• Develop publication plans by conducting data gap analysis to inform publication strategy and publication mapping/planning and provide oversight of all publications including posters, abstracts, and manuscripts at the global level to ensure appropriate dissemination of scientific messages
• Partner with internal and external stakeholders to review and edit publications and external communications to ensure content is scientifically accurate and of high quality
• Lead the development and execution of medical educational initiatives in support of defined educational strategies
• Develop Scientific platform to inform the development of publication plan, communication plan, proactive and reactive slide decks for KOL and advocacy engagements
• Lead the medical review process for the Neuromuscular therapeutic area
• Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders
• Serve as scientific/clinical knowledge expert for Neuromuscular therapeutic area(s) and disease states to internal and external stakeholders
• In collaboration with the External Affairs Team, support external initiatives in alignment with program and product strategies.
• Generate a compelling strategy around not only patient advocacy but also professional advocacy
• Develop and manage budgets and timelines for all Neuromuscular medical affairs initiatives as described in the Medical Affairs plan and in alignment with IPT’s overarching program strategy
• Develop, execute and/or support Therapeutic Area Scientific/Clinical Advisory Board meetings

Minimum Requirements

• Doctorate level or higher degree and 12+ years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development with increasing responsibilities, complexity, and accountability OR Medical Degree (MD) with 8+ years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development with increasing responsibilities, complexity, and accountability
• US, Global and major EU experience
• Significant experience in developing medical strategies and publication plans in early stages of product life cycle (pipeline medical affairs)
• Significant experience in advisory board planning from needs assessment, recruiting/contracting KOLs, determining the objectives of the Ad board, running the Ad board and finalizing the report is needed
• Experience with phase I-IV clinical research
• Strong understanding of drug development and commercialization concepts
• Experience driving transformation within your organization in a cross-functional capacity
• Successful product launch experience
• Technical skills covering end to end lifecycle management, launch planning and execution, and disease area shaping
• Experience creating high quality integrated evidence and scientific external engagement packages
• Track record working within large, complex organizations influencing R&D and partnering with and understanding the global landscape
• Cross-functional senior leadership experience leading strategies for different cross-functional medical affairs teams
• Proficient in presenting new ideas, initiatives, and business rationale to Board and C-level leaders to gain alignment and update on progress
• Track record for attracting and developing talent and optimizing team performance in direct and matrixed leadership roles
• ~25% travel (Primarily US and Europe)

Preferred Education, Experience and Skills

• MD or equivalent is preferred
• Specialty clinical training and patient care experience in neurology and/or neuromuscular therapeutic area
• Experience with Gene Therapy, rare disease, immunology, neuroscience, and/or neuromuscular therapeutic areas is preferred

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.