Director, Global Medical Information & Scientific Communications
South San Francisco, CA - USA
Job Summary
About Allogene:
Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand more reliably and at greater scale to more patients.
About the role:
Allogene Therapeutics is seeking an experienced Director Global Medical Information & Scientific Communications to lead the execution of a comprehensive medical information and scientific communications strategy across pipeline assets. This role will be accountable for defining and executing the global medical information and scientific communications strategy establishing operational excellence and ensuring compliant high-impact scientific exchange aligned with Allogenes mission to advance allogeneic CAR-T therapies for patients with serious diseases.
In addition this role will provide site-support for selected global trial sites supporting the ALPHA3 study partnering closely with Clinical Development Clinical Operations and Field Medical leadership (E.g. SIV attendance PI relationship-building 1:1 investigator meeting facilitation).
The position is remote based in the U.S. and reports into Medical Affairs leadership.
The ideal candidate is interested in working in a fast-paced dynamic and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.
Responsibilities include but are not limited to:
- Lead Medical Information (MI) support for assigned pipeline assets including development of processes and SOPs for intake/triage of unsolicited inquiries development of scientifically balanced responses and documentation of inquiry handling. Maintain the Medical Information (MI) content library (e.g. SRLs FAQs and non-standard response letters) across pipeline assets.
- Drive Medical Communications (MC) for assigned pipeline assets in partnership with internal stakeholders and external vendors/agencies including development of the scientific platform and creation/review of scientific communication deliverables (e.g. slide decks congress materials FAQs field medical materials) through MRC review and warehousing.
- Lead publications planning and execution for assigned pipeline assets in alignment with Good Publication Practice (GPP) and authorship standards (e.g. ICMJE) including publication plan development review committee coordination and support of abstracts posters/orals and manuscripts with external authors.
- Engage and maintain relationships with external scientific stakeholders (e.g. investigators KOLs and societies) to support publication and trial site support activities as needed.
- Ensure all activities adhere to applicable regulations and company policies including appropriate use of approved materials documentation standards and medical/legal/regulatory review requirements.
- Maintain scientific expertise in relevant disease areas with the ability to translate complex data into clear audience-appropriate scientific content.
- Execute Field Medical-aligned activities for assigned ALPHA3 global study sites in (e.g. site education and/or scientific discussions as requested).
- Other duties as assigned.
Position Requirements & Experience:
- Advanced degree in life sciences field (APN PhD PharmD MD)
- 4-6 years of experience in Medical Affairs (Medical Information Medical Communications Publications or a combination) within the pharmaceutical/biotech industry; experience supporting pipeline/launch readiness preferred.
- Working understanding of medical affairs principles the end-to-end lifecycle of scientific content (e.g. MI response documents medical communications materials and publications) building HCP relationships and engaging in scientific exchange.
- Willingness to travel (up to 40% of time including overnight travel) to support global ALPHA3 sites and attend internal meetings and scientific congresses as needed.
- Excellent communication presentation and time management skills required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
- Familiarity with applicable legal regulatory and compliance requirements for scientific exchange and clinical trial site interactions; ability to operate compliantly across multiple geographies.
- Ability to partner with key internal stakeholders to understand key objectives and to drive plans that achieve or exceed these
- Ability to effectively work in a fast-paced biotech environment while dealing with ambiguity and ability to work independently and as part of a team
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines and strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S. and able to travel internationally for business (i.e. obtain/maintain a valid passport and any required visas/entry documentation as needed).
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200000 to $250000. Actual pay will be determined based on experience qualifications geographic location business needs and other job-related factors permitted by law.
As an equal opportunity employer Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other non-job-related characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
#LI-REMOTE #LI-TF1
Required Experience:
Director
About Company
REDEFINING THE FUTURE OF CELL THERAPY WITH OUR AlloCAR T™ PRODUCT PLATFORM INNOVATION Multiplex gene-engineering and gene-editing capabilities Proprietary lymphodepletion platform State-of-the-art manufacturing Opportunity for product optimization SEE OUR PIONEERING PLATFORM >> KEY PR ... View more