SpringWorks Therapeutics Medical Director, Clinical Development in Durham, North Carolina
About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing, and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two registrational clinical trials in desmoid tumors and neurofibromatosis. There are also programs addressing genetically defined cancers and multiple collaborations with biopharmaceutical companies developing BCMA- directed therapies in multiple myeloma. 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 industry leaders to expand its portfolio.
At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we?re in it together. We are looking for ambitious, smart, and hardworking colleagues to join our growing team.
Are you a SpringWorker?
How much do you care?How well do you partner with others?How fast do you move?Are you a problem solver?Are you comfortable challenging convention?
Does this sound like fun?
About the Role:
Ideal role for a MD proficient in clinical practice, who is seeking an opportunity to develop a career in the biopharmaceutical industry, or an MD who has entered the biopharmaceutical industry and desires to advance in clinical development. This position is clinical intensive and requires peer-level interactions with academic investigators and industry collaborators. There will be broad and in-depth exposure to multi-disciplinary teams including experts in biometrics, clinical trial operations, clinical pharmacology, pharmacovigilance, and medical affairs. Expectations in the first year include medical monitoring of ongoing trials and initiation of new trials. Reporting line is to the Vice President of Clinical Development, a board-certified physician in Internal Medicine, Hematology, and Oncology with twenty years? pharmaceutical industry experience.
Location: Stamford, CT, Raleigh-Durham, NC, or Remote.
Support and or lead the Clinical Development of SpringWorks? s pipeline
Authorship of clinical protocols
Prepare and present the relevant topics in Clinical Trial Site Initiation Visits
Advise investigators on study-related medical questions
Assess ongoing clinical trial data
Authorship of clinical study reports
Formulation and execution of clinical and regulatory strategy including clinical trial completion, health authority advice, filings, labeling, and asset life cycle management.
Extensive collaboration with biometrics, data management, clinical operations, pharmacovigilance, and clinical pharmacology.
Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
Collaborate with global and field Medical Affairs on medical plans, publications, and thought leader interactions.
Review investigator-initiated and cooperative group collaborative clinical trial proposals.
Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
About You: Required Education, Skills, and Experience
- Requirement of MD or MD degree equivalent with at least 3 years of licensed clinical practice in a direct patient care setting or completed a formal clinical residency or fellowship at an accredited academic hospital
Preferred Education, Skills, and Experience
Board certification or equivalent eligibility in oncology or hematology, preferred
2 years? experience in biopharmaceutical clinical development, preferred
Other Skills / Attributes:
Knowledge of FDA/EMA guidance (prior interaction with FDA or other health authorities preferred)
Knowledge of GCP and ICH guidelines
Excellent communication skills and an ability to articulate the company?s scientific, clinical, and regulatory strategies and progress to a wide audience, including the leadership team, academic collaborators, potential and existing industry partners, and the scientific and medical community
Ability to travel up to 20% as needed
Organization SpringWorks Therapeutics
Employee Status Regular Full -Time
Benefits Competitive compensation and benefits package
SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual?s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.