Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

SUMMARY:

The Clinical Project Manager is responsible for operational aspects of planning, implementation, execution, and management of one or more clinical research studies. ensuring clinical trial is completed within established timelines and of the highest quality.

Oversee management of CROs, and third-party vendors to ensure work performed is in accordance to the Statement of Work and within the approved budget. Authors, reviews, and approves various study related documents and plans. Proactively evaluates study risks and works cross functionally to implement solutions and mitigations as required. Responsible for the financial management of assigned studies and develops and oversees study timelines in coordination with cross-functional team, COL, and Program team. Ensure inspection readiness from a global level by engaging trial team(s) and other stakeholders, with a focus on the Trial Master File (TMF) and general clinical preparedness. Responsible for ensuring that inspection lessons learned are captured and shared.  Ability to appropriately escalate issues that are unresolvable at a study team level to the COL and other leadership as applicable.

RESPONSIBILITIES:

• Responsible and accountable for the daily activities for the execution of assigned clinical trials from start-up through close-out and responsible for delivery by cross functional teams and CROs/vendors.
• Contributes to the development of study protocols and protocol amendments and responsible for creation of ICFs with cross-functional input.
• Leads the planning, preparation and development of clinical trial materials, study specific training, investigator meetings and other ad-hoc meetings, and documents as required.
• Responsible for ensuring clinical trial Core team members are trained on study specific documents and training documentation is available in TMF.
• Responsible for identifying potential risks and ensuring cross functional discussions occur and mitigations implemented or escalation through Clinical Operations Lead (COL) occurs.
• Direct Contribution to the development and clinical review of Case Report Forms, IRT and User Acceptance Testing (UAT) and the creation of study specific eCRF completion guidelines.
• Responsible/accountable for finances ensuring the assigned clinical trial(s) remain within the pre-approved budget.
• Responsible/accountable for content, accuracy, and maintenance of study files (TMF, etc.) and inspection readiness of the trial.
• Serves as the subject matter expert for the study during regulatory inspections.
• Responsible/accountable for ensuring all close-out activities occur per applicable SOPs/processes and database lock occurs per agreed upon timelines.
• Generates tools and provides guidance and active mentorship to junior team members.
• Additional activities and responsibilities may be assigned based on Company and study specific requirements.
• Up to 20% domestic and/or international travel may be required.

“Please not we are open to hiring at different levels/job grades for this position based on candidate experience.”

• Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred.  Exceptions can be made for individuals with multiple years of experience in Clinical Operations.
• Experience (6+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization.
• Strong knowledge of clinical research processes and clinical research terminology.
• In-depth knowledge of ICH-GCP guidelines and local regulations.
• Knowledge of regulatory requirements and guidelines governing clinical research.
• Superior organization skills.
• Strong attention to details in composing and reviewing/editing materials.
• Excellent analytical and problem-solving skills.
• Ability to establish priorities, scheduling, and meeting deadlines.
• Strong written, oral communication and presentation skills and ability to present at Team meetings.  
• Ability to reason independently and recommend specific solutions in clinical settings.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands under tight timelines.
• Demonstrated leadership skills.
• Ability to work successfully within a cross-functional team.
• Ability to effectively interact with investigators, vendors, peers, and leadership.
• Strong aptitude with relevant technology platforms (e.g., eTMF, EDC, CTMS, IRT/IVRS) and project management software programs.

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), teamembers 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