Kailera Therapeutics, Inc.

Medical Director, Pharmacovigilance

Waltham, Massachusetts · Director · Full-time

Sponsorship not specified$254k-$305kDetected 15 days ago

GCPData AnalysisData ScienceData VisualizationComplianceBudgetingFDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaboration

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.

Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies, ensuring proactive identification and mitigation of safety risks
Collaborate with cross-functional stakeholders to integrate safety considerations into clinical development, post-marketing activities, and evidence-generation strategies
Lead and inspire a team of PSPV MDs, scientists, and operational colleagues, fostering a culture of accountability, scientific excellence, and collaboration
Contribute to the design, implementation, and enhancement of drug safety processes and systems to ensure high-performance PV operations
Drive the development of SOPs, work instructions, and "fit-to-purpose" pharmacovigilance training for internal and external partners

8+ years of experience in global pharmacovigilance
2+ years of experience in clinical practice or academic medicine
Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
Proven experience with authoring or contributing to clinical study and regulatory submission documents
Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Ability to influence and keep teams focused and motivated
Strong ability to communicate complex issues clearly

Ph.D. degree is a plus
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

$254,000 - $305,000 USD
For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
This range represents the company's good-faith estimate of the salary at the time of posting.

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.
Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions.
The medical director will collaborate extensively across and within their own function to advance Kailera's pharmacovigilance strategy to support the company's evolving pipeline, innovation, and mission.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

tive hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-rel

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