Senior Director, Medical Affairs
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Job Description
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
Senior Director, Global Medical Affairs, PD/MSA IPT (IPT) is responsible for development and delivery of the Medical Affairs plan and strategies for AskBio's CNS clinical development programs. This individual will be the senior Medical Affairs leader on AskBio’s PD/MSA IPT, with functional reporting into the Senior Vice President of Global Medical Affairs.
This hybrid role will be based in our Raleigh-Durham, NC or Philadelphia, PA Headquarters.
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 Commercial, Clinical Development, Clinical Operations, Corporate Communications, R&D, and other functions to develop and implement global
- Medical Affairs strategies for the CNS 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 publication plan and provide oversight of all publications including posters, abstracts, and manuscripts at the global level to ensure appropriate alignment between relevant teams
- Lead the development and execution of medical educational initiatives in support of new technology, studies, indications, and products
- Partner with technical experts to review and edit publications and external communications to ensure content is scientifically accurate and of high quality
- Lead the medical review process for the CNS therapeutic area
- Serve as scientific/clinical knowledge expert for company products and related therapeutic area(s) to internal and external stakeholders
- In collaboration with the External Affairs Team support external initiatives in alignment with program and product strategies
- Manage external agencies and medical writing contractors supporting the publication and medical communication planning and development activities
- Develop and manage budgets and timelines for all CNS medical affairs initiatives as described in the Medical Affairs plan and in alignment with IPT overarching program strategy
- Develop, execute and/or support Therapeutic Area Scientific/Clinical Advisory Board meetings
- Attend and support key external medical/scientific meetings
Minimum Requirements
- Medical degree with Specialty clinical training and patient care as a neurologist/neurosurgeon; OR PharmD with a minimum of 3 years' experience in clinical development or medical affairs in neurology and/or neurosurgery.
- 12+years' relevant experience; · Minimum of 5 years’ experience working in the biopharmaceutical industry in medical affairs and/or commercial roles with increasing responsibilities, complexity, and accountabilities
- Significant experience in developing medical strategies and publication plans
- Experience with phase I-IV clinical research ·
- Strong understanding of drug development and commercialization concepts · Prior 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 acting as an evangelist for transformation and innovation
- 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
- ~50% travel (Primarily US and Europe)
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 talent@askbio.com.