Senior Director, Global Patient Safety & Risk Management
Company: Scientific Search
Location: Somerville
Posted on: May 14, 2022
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Job Description:
Senior Director, Global Patient Safety & Rick
ManagementLocation: Cambridge, MAadditional jobs can be found at
www.ScientificSearch.comThe role of the Senior Director of GPSRM is
to provide guidance, expertise, and strategic direction on all
aspects of clinical safety throughout the lifecycle for multiple
products/programs both in development and post marketing. This is a
highly visible role that will interface across all levels and
functional areas and will need to partner closely with the clinical
development, regulatory, medical affairs, and commercial teams. The
exceptional candidate that we seek will have a proactive and
innovative approach and a flexible, hands-on nature that works with
a high sense of urgency. ***MUST HAVE MEDICAL DOCTOR CREDENTIALS***
-Summary of Key ResponsibilitiesLead active monitoring and
continued assessment of safety profile through systematic signal
detection and critical review of aggregate safety data and
literature during all phases of the life-cycle of a defined
portfolio of medicinal products.Lead a multifunctional team (Safety
Risk management Team) regarding safety relevant topics and escalate
all safety relevant matters to the appropriate decision-making
level with proposals for solutions based on analysis of the
available information. Provide guidance for the development of
global safety and risk management strategies for a portfolio of
products.Support the Executive Director of GPSRM in various duties
including onboarding and mentoring of safety physicians, PV
Scientists and GPSRM Fellows, building safety science capabilities
and exploring innovation in safety science to support the unique
requirements of portfolio,Guide the clinical development teams
regarding all aspects of clinical safety, including trial design,
appropriateness of safety endpoints, analysis, and interpretation
of safety data. Serve as a Clinical Trial Review Board member.Be
accountable for timely delivery of all safety deliverables towards
Clinical Study Reports, preparations for market applications and
all other regulatory documents.Serve as the safety expert providing
strategic input to key stake holders in relation to product safety,
understand the business strategy for the product and be
knowledgeable about the (medical) context of the respective product
class. Be subject matter expert for safety relevant discussions
with regulatory agencies and other significant external bodies.Be
the accountable content owner for all safety relevant content of
relevant safety documents during clinical development (e.g. DSUR,
Development Risk Management Plans, Safety Analysis Plans) and post
approval (e.g. PSUR, RMPs, medical expert statements and answers to
HAs requests, publications). Be content owner for safety relevant
communications such as DHCP letters and company
statements.Collaborate with pharmacovigilance and drug safety
colleagues from licensing partners to align on a harmonized
approach to identifying, evaluating and communicating safety
issues.Provide guidance for the development of worldwide
pharmacovigilance strategies within company goals, including the
support to Safety Operations for establishing and maintaining
policies and procedures for the Clinical Drug Safety
Department.QualificationsOur client prides themselves on their
entrepreneurial, fast-paced environment where success is rapidly
rewarded. There is a strong pipeline, significant resources, and
every intention of continuing the phenomenal rate of success and
growth. These folks have been voted one of the top places to work
in Boston, 7 years in a row! -This position offers an opportunity
to have tremendous impact on the growth of the company. The culture
values hard-work, creativity, flexibility, a sense of humor and a
hands-on, problem-solving attitude. The ideal candidate will have
the following mix of personal and professional
characteristics:Medical Degree with a minimum of 3 years of medical
practice is required;Must have a minimum 5 years in
pharmacovigilance and/or clinical research/clinical safety/clinical
development/medical affairs experience in the pharmaceutical
industry.Clinical safety experience - early phase through
post-marketing - including initial filing experience. Risk
management experience including writing of initial and follow-up
plans, strategizing on post-marketing safety studies and/or REMS
programs.Experience interfacing with regulatory and health agencies
on a global basis. Experience with FDA advisory committee
preparation and presentation desirable.Leadership and people
management skillsSound clinical acumen and a wide range of
therapeutic area knowledge.Ability to synthesize and analyze safety
data from various sources. Proficiency in problem-solving within a
highly complex environment.Strong communications skills, both
written and spoken, ideally with demonstrable experience in medical
/ scientific writing.Excellent networking and relationship building
skills for successful cooperation with internal and external
customers.Expertise in international regulations governing drug
safety. Experience in managing compliance or audits. Working
knowledge of relevant FDA, EU, ICH guidelines, initiatives and
regulations governing both Safety reporting and processing for
clinical trial environments.Knowledge of clinical research
methodology, clinical epidemiology/biostatistics, pharmacovigilance
tools and processes and relevant regulatory framework.Excellent
interpersonal and decision-making skills. Strong influencing skills
with the ability to quickly earn credibility across other
functional areas. Ability to work in fast-paced environment with
rapidly approaching timelines is importantIf employed in the U.S.,
being fully vaccinated against COVID-19 as defined by the Centers
for Disease Control and Prevention (CDC) is requiredIf you are
interested in learning more, please email Michelle Lair at
MichelleL@ScientificSearch.com
#LI-ML1Type: Direct HireCategory: Biotech Company
Keywords: Scientific Search, Somerville , Senior Director, Global Patient Safety & Risk Management, Executive , Somerville, Massachusetts
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