Job description
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two late-stage clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
We give it our all every day because we believe in the power of targeted oncology to help people with cancer. If you recognize yourself in us, then we'd like to meet you. The answers are waiting – and we need your help finding them.
About the Role:
The Global Pharmacovigilance Medical Fellow will direct a variety of core medical activities within the safety organization to support the development and evaluation of the safety profile of multiple products. This individual will serve as the representative of the Head of Global Pharmacovigilance in various roles as designated. This person will function as an internal pharmacovigilance consultant to other components of the company. This individual will be an integral and leading member of multiple project teams and will serve as an internal pharmacovigilance consultant for individual assets and provide critical and strategic pharmacovigilance input into the safety aspects of the compounds.This person will provide mentoring to other members of the Pharmacovigilance team. This position requires an accomplished safety expert with extensive experience and excellent critical and strategic thinking skills who can provide leadership, and functional and technical expertise, while collaborating with multiple stakeholders.
Responsibilities Include:
- Provide strategic guidance for the development of safety information for all clinical and pre-clinical assets in development, including risk anticipation, data collection, and data analysis and interpretation.
- Serve as a consultant to clinical development teams, and their Pharmacovigilance members, concerning strategies for safety signal detection and data assessment, and other aspects of Pharmacovigilance.
- Represent Global Pharmacovigilance to other components of the company as delegated by the Head of Global Pharmacovigilance.
- Provide strategic guidance for the development of safety sections of regulatory documents and submissions (DRMPs, RMPs, INDs, NDAs, CTAs, CSRs, protocols, IBs, ICFs, ad-hoc Health Authority responses).
- Provide strategic guidance for the publication strategy for assigned assets and prepares/contributes to presentations for scientific conferences and prepares/contributes safety content for manuscripts for publication in peer-reviewed journals.
- Provide strategic input for the development of Pharmacovigilance policies and procedures.
- Coach and mentor Pharmacovigilance team members
- Lead pharmacovigilance aspects for due diligence efforts for potential acquisition of products and/or technologies
- Perform other duties and responsibilities as assigned.
About You: Required Education, Skills, and Experience
- Education: Medical Doctor degree required
- Requires a valid license to practice medicine
- 18+ years Pharmacovigilance/related experience, including experience in leading pharmacovigilance for products in all phases of development, preparation of safety documents for market authorization submission, safety signal management/detection activities, aggregate reports, and critical review of safety data
- 3+ years of clinical practice experience
- Knowledge of, and experience in, the creation of all Pharmacovigilance regulatory reports, including aggregate report, DSURs, PSURs/PBRERs, NDA Periodic Reports, IND Annual Reports, market authorization applications, and (D)RMPs
- Thorough understanding of the drug development process and context applicable to the development of safety information and labeling
- Excellent critical thinking skills and proven ability to apply them in the context of pharmacovigilance
- Excellent strategic thinking skills
- Thorough knowledge of all Pharmacovigilance requirements and activities, including Risk Management, and their practical application in the production of Pharmacovigilance regulatory documents
- Knowledge of MedDRA terminology and its application
- Ability to lead and influence key decisions and stakeholders cross-functionally and externally
- Ability to persuade others of possible future consequences of current actions, and effective mitigation strategies.
- Ability to coach and mentor
- Demonstrated ability to navigate in a fast-paced environment with changing priorities, and to help other do the same
- Excellent verbal and written communication skills including ability to present to both internal and external partners
- This position must be able to work East Coast hours.
- Ability to travel occasionally including overnight stay (<10%)
The expected salary range for this position is $245,000.00 - $320,000.00. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.
At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.
SpringWorks is an equal employment opportunity employer that is strongly committed to equal employment opportunities for all individuals. The Company does not discriminate in employment opportunities or practices on the basis of actual or perceived sex (including pregnancy, childbirth, breast feeding 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, 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, domestic violence victim status, sex offense or stalking victim status, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws.
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.
GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing hr@springworkstx.com . Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.
Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.
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