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Senior Director, Clinical Operations

Remote: 
Full Remote
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Offer summary

Qualifications:

Bachelor’s Degree in a scientific discipline; advanced degree preferred., Minimum 12 years of experience in biotech/pharmaceutical/CRO settings, with at least 10 years in clinical operations., Proven leadership experience with a track record of managing complex drug development trials., Strong knowledge of clinical operations management and federal regulatory requirements..

Key responsabilities:

  • Develop and implement clinical project plans aligned with corporate objectives.
  • Oversee clinical operation activities including trial management and vendor management for clinical trials.
  • Proactively identify and resolve issues that may impact clinical study timelines or budgets.
  • Contribute to global clinical and regulatory submissions and develop departmental SOPs.

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tactical. https://www.wearetactical.com/
51 - 200 Employees
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Job description

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
 
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

Scholar Rock is looking for a director-level subject matter expert to build and lead a clinical operations team focused on advancing our immuno-oncology clinical programs while upholding our core values and staying true to our mission.  Reporting to the Head of Clinical Operations, the Sr. Director, Clinical Operations will play a key role in the operational planning, oversight, and delivery for one or more clinical programs. 

Position Responsibilities:
  • Develop and implement clinical project plans in accordance with corporate objectives
  • Evaluate outsourcing partnerships and define go-forward strategy for identifying, engaging and managing long term strategic partnerships
  • Provide oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical trials. 
  • Contribute to key study documents in conjunction with other functional area leads (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
  • Proactively develop and implement hiring plans to attract, recruit, on-board and retain best in class talent to effectively execute against program milestones
  • Ensure clinical trial compliance with all SOPs and GCP/ICH guidelines; maintain an inspection readiness state throughout the lifecycle of the trial 
  • Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget
  • Identify, evaluate, and recruit clinical trial sites
  • Contribute to global clinical / regulatory submissions
  • As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency
  • Undertake line management responsibilities for assigned team members, serving as coach and mentor 
  • Contribute to the development of departmental SOPs and work instructions
  • May require travel, including international travel

  • Candidate Requirements:
  • Bachelor’s Degree (scientific discipline preferred); advanced degree preferred 
  • Minimum 12 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 10 years of clinical operations experience; minimum 5 years in a supervisory role
  • Proven record of success running complex drug development trials
  • Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
  • Highly organized, outcome oriented, self-motivated performance
  • Comfortable in a fast-paced environment with the ability to adapt to change
  • In depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
  • Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
  • Excellent working knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
  • Outstanding oral and written communication skills including experience authoring clinical protocols and other key trial documents
  • Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Other Skills

    • Leadership
    • Adaptability
    • Communication
    • Team Management
    • Problem Solving

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