Global Pharmacovigilance Medical Director

SpringWorks Therapeutics • Remote (Durham, NC, US) • $222.79k - $292.50k / year • 2w ago

About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

Your Role:

The Global Pharmacovigilance Medical Director will lead a variety of core medical activities within the safety organization to support the monitoring and evaluation of the safety profile of assigned products. This individual will be an integral member of multiple project teams and will serve as the pharmacovigilance lead for individual asset(s) and/or provide critical and strategic PV input into the safety aspects of the compounds. This position requires an experienced and accomplished safety expert who can provide functional and technical expertise while collaborating with multiple stakeholders.

Location Classification – Hybrid:

This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid

Essential Duties and Responsibilities:

Design and execution of PV strategy to lead the ongoing worldwide signal detection monitoring, product risk-benefit assessment, and safety assessment activities of assigned products/indications in all phases of clinical and post-marketing development, including representing the safety of the compound to regulatory authorities.
Contribute safety sections to INDs, NDAs, CTAs, CSRs, protocols, IBs, ICFs, and other regulatory documents/submissions.
Responsible to develop and maintain RSI, CCSI/safety sections of CCDS and local labels
Prepares dRMPs/RMPs and coordinates with input from stakeholder departments such as Medical Affairs, Clinical Research, Data Management, Pre-clinical, Quality Assurance and Regulatory Affairs.
Coordinates and participates in the development of ad-hoc Health Authority responses as well as medical safety responses to customers including HCPs and consumers.
Responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
Accountable for medical content of aggregate reports and supporting GPV scientist to produce aggregate reports.
Prepares/contributes to presentations for scientific conferences and prepares/contributes safety content for manuscripts for publication in peer-reviewed journals.
Assist in due diligence efforts for potential acquisition of products and/or technologies
Reviews SUSARs, assures outputs from the safety database as well as timely completion of the Analysis of Similar Event Summaries for FDA submissions.
Participation in clinical study team meetings and activities.
Perform other duties and responsibilities as assigned.

Role Requirements:

Education: MD or PharmD
9+ years of pharmaceutical industry or equivalent experience; 4+ years of pharmacovigilance experience preferred
1+ years of relevant clinical experiences in patient clinics/hospitals
Knowledge of Aggregate Report requirements and experience in the creation of DSURs, PSURs, NDA Periodic Reports, IND Annual Reports, and other regulatory documents.
Experience in the synthesis of aggregate safety data and translating it into public health and regulatory impact
Knowledge of MedDRA terminology and its application as well as experience with common safety database systems (Argus).
Working knowledge of Risk Management requirements and activities.
Thorough understanding of the drug development process and context applicable to safety surveillance activities.
Participation in clinical study team meetings and activities.
Ability to lead and influence key decisions and stakeholders cross-functionally and externally as an individual contributor.
Anticipate future consequences of actions taken in the moment, to prevent or enhance the consequences as appropriate
Model SpringWorks Leadership Principles to drive a collaborative function that embraces innovation and drives superior employee experience through growth management.
Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
Ability to travel occasionally including overnight stay driven by business need.
Relocation available.

SpringWorks Leadership Principles:

Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

Compensation and Benefits:
The expected salary range for this position is $222,789.00 - $292,500.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.

DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I

EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

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