Senior Director, Clinical Research Scientist

Karyopharm Therapeutics•Newton, MA

15h

About The Position

Role Overview & Key Functions: The Sr Director, Clinical Research Scientist position serves a key role within the Clinical Development R&D team. The Sr Director, CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. Reporting to our Senior Vice President, Clinical Development, you will positively impact patients’ when you: Support assigned study level activities for one or more clinical studies. Develop thorough understanding of assigned protocol and protocol requirements Support study activities as applicable: Liaison between medical monitor, clinical operations, and CRO Participate in the protocol development process; including writing, reviewing, adjudication/resolution of cross functional comments, ensuring high quality final document Lead the medical data review process during ongoing study, including individual patient review for purposes of data cleaning, and aggregate data review for safety and protocol conduct purposes Participate in the creation of and the review of clinical study reports (CSRs) Contribute to the creation of and the review of Regulatory Documents (e.g., IB, Briefing Books, and regulatory submission documents) in collaboration with medical writers with minimal to moderate supervision Review/Edit Master Informed Consent Forms (ICF); Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation Active contributor to Investigator Meeting and Site Initiation Visit presentations Active contributor to activities related to data generation and validation, including CRF creation, clinical data review, data cleaning, communication as needed to resolve data queries, contribute to development of data review plans, support medical director and pharmacovigilance physicians in data review (generation of reports, action plans, trend identification), etc.) Provides mentoring to more junior clinical researcher scientists as needed based upon past experience and prior understanding of roles and responsibilities. Collaborate with study team members (Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality data output Participate in operational excellence projects as appropriate and audit readiness activities Candidate Profile & Requirements: Degree in Life Sciences (advanced degree preferred) 12 years of pharmaceutical clinical research experience including prior experience in pharma/biotech. Prior experience supporting and participating in regulatory inspection activities. Prior experience supporting regulatory submissions including NDA, sNDA or equivalent (outside the US/FDA). Comprehensive knowledge of oncology drug development with some direct experience required Proficient knowledge of GCP/ICH, study design, statistics, clinical operations within the oncology therapeutic space. Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels. Proficient knowledge and skills to support program specific data review, trend identification, data interpretation Proficient in Medical Terminology and medical writing skills Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or similar data reporting tools Our Value Proposition: At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between. What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission. Check out our Culture Video ! What We Offer: In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills. A culture of employee engagement, diversity, and inclusion Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity! Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement. Wellness Program with a monthly stipend. Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends. Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs) Cell phone allowance

Requirements

Degree in Life Sciences (advanced degree preferred)
12 years of pharmaceutical clinical research experience including prior experience in pharma/biotech.
Prior experience supporting and participating in regulatory inspection activities.
Prior experience supporting regulatory submissions including NDA, sNDA or equivalent (outside the US/FDA).
Comprehensive knowledge of oncology drug development with some direct experience required
Proficient knowledge of GCP/ICH, study design, statistics, clinical operations within the oncology therapeutic space.
Excellent verbal, written, communication and interpersonal skills.
Must be able to effectively communicate and collaborate across functions and job levels.
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
Proficient in Medical Terminology and medical writing skills
Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or similar data reporting tools

Responsibilities

Support assigned study level activities for one or more clinical studies.
Develop thorough understanding of assigned protocol and protocol requirements
Support study activities as applicable: Liaison between medical monitor, clinical operations, and CRO
Participate in the protocol development process; including writing, reviewing, adjudication/resolution of cross functional comments, ensuring high quality final document
Lead the medical data review process during ongoing study, including individual patient review for purposes of data cleaning, and aggregate data review for safety and protocol conduct purposes
Participate in the creation of and the review of clinical study reports (CSRs)
Contribute to the creation of and the review of Regulatory Documents (e.g., IB, Briefing Books, and regulatory submission documents) in collaboration with medical writers with minimal to moderate supervision
Review/Edit Master Informed Consent Forms (ICF); Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation
Active contributor to Investigator Meeting and Site Initiation Visit presentations
Active contributor to activities related to data generation and validation, including CRF creation, clinical data review, data cleaning, communication as needed to resolve data queries, contribute to development of data review plans, support medical director and pharmacovigilance physicians in data review (generation of reports, action plans, trend identification), etc.)
Provides mentoring to more junior clinical researcher scientists as needed based upon past experience and prior understanding of roles and responsibilities.
Collaborate with study team members (Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality data output
Participate in operational excellence projects as appropriate and audit readiness activities

Benefits

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), team members enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.
A culture of employee engagement, diversity, and inclusion
Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
Wellness Program with a monthly stipend.
Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
Cell phone allowance

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