Clinical Development Associate Director
Clinical Development Associate Director
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Job Description
About SpringWorks Therapeutics:
SpringWorks is a commercialstage biopharmaceutical company applying a precision medicine approach to developing and delivering lifechanging 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 latestage 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:
As the integral member of the study team and program development team the Clinical Development Associate Director will be responsible the design and of clinical trials within the SpringWorks clinical programs in oncology and rare diseases. In addition the Clinical Development Associate Director is responsible for the design preparation implementation and reporting of clinical study protocols in all phases of development. The Clinical Development Associate Director will work closely with Clinical Operations Clinical Pharmacology Data Management Pharmacovigilance Field Medical and Biometrics to help manage the clinical trials at SpringWorks.
Location Classification Remote:
Officially classified as working fulltime from employees home office within the United States or respected region with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs. #LIRemote
Essential Duties and Responsibilities:
- The responsibilities of the Clinical Development Associate Director during the clinical trial life cycle will include but are not limited to the following activities:
- Design and writing of protocol CRF data management plan statistical analysis plan and endpoint centric study manuals
- Lead the following activities in the areas related to the Clinical Scientists expertise (e.g. response evaluation biomarker assessment imaging etc.
- Selection and management of clinical study support vendors and clinical study sites with respect to functional capabilities related to pertinent endpoints and study procedures
- Engagement and education of investigators (e.g. Investigators Meeting Site Initiation Visit data reviews)
- Lead data querying during the clinical trial conduct and support external data reconciliation (Biomarkers Imaging etc.
- In collaboration with Data Management and Medical Monitor prepare the data review plan and perform data reviews using patient profiles or other reporting formats and tools
- Assessment of reported protocol deviations and trends and potential study impact
- Preparation and conduct of meetings to review clinical trial results (e.g. cohort review DMC Steering Committee)
- Analysis and interpretation of clinical trial results and trends including preparation of the clinical study report and associated abstracts and/or publications
- The responsibilities of the Clinical Development Associate Director at the program level will include but are not limited to providing guidance and input to the following documents in the areas related to expertise (e.g. response evaluation biomarker or imaging strategy):
- Investigators Brochure
- Clinical Development Plan with particular emphasis on the Biomarker and Imaging strategy and analysis plan
- Regulatory submissions
- Publication strategy and plan for the program or therapeutic area
- Individual publications and other scientific/clinical information aligned with the overall program strategy
- Ensure consistent practices in the conduct and management of scientific approaches across trials and programs as needed
- Maintain their own and departmental awareness of scientific information
- Evaluate therapeutic area innovation and competitive landscapes
- Perform other duties and responsibilities as assigned.
Role Requirements:
- Education: Doctoral Degree Required (PhD PharmD etc.
- 7 years clinical trial research experience in pharmaceutical and/or biotechnology industry
- Postgraduate research experience preferred
- Oncology therapeutic area preferred
- Ability to lead influence and shape scientific planning conduct and analysis in alignment with the applicable program strategy
- Well versed in critical review of scientific information with good working knowledge of GCP and ICH guidelines.
- Understanding of steps required to set up and successfully manage delivery of all phases of studies.
- Excellent interpersonal skills with proven high performance in a study and program team matrix.
- 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 assistance available.
SpringWorks Leadership Principles:
- Change Steward Recognize that change is essential; set goals that align to the Companys 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 $$200000.00. Actual pay will be determined based on experience qualifications location and other jobrelated factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We offer bestinclass 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 hereBenefits.
DE&I:
We believe in fostering a culture of belonging. Explore how we are committed toDE&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 toallaspects 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.
Privacy:
Upon submission of this form I understand that SpringWorks Therapeutics is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S.. Information about SpringWorks Therapeutics privacy practices can be found atPrivacy Policy Springworks springworkstx.
Required Experience:
Director
Employment Type
Full Time
