Associate Director, Clinical Development

POSITION SUMMARY:

The Associate Director, Clinical Development is a leadership role responsible for executing Natera’s clinical development objectives. The core responsibilities of the role include outlining clinical research requirements (clinical study plans, protocols and supporting documents), forming relationships with centers conducting research in women’s health and driving on-time execution of clinical research projects. This role will focus on delivery of complex or multi-center investigator sponsored studies and consortium projects.

PRIMARY RESPONSIBILITIES:

• Drive the design and timely execution of clinical research plans, including clinical studies and investigator-initiated studies, research projects
• Build relationships with KOLs, consortiums, clinical site staff, and external partners to fill identified data gaps
• Develop clinical project execution timelines and provide status updates to senior management to ensure timely delivery of program milestones.
• Drive contracting, including budget approvals, with academic centers and community practices participating in Natera research studies.
• Participate in due diligence activities to evaluate external opportunities that support Natera’s business objectives.
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
• Lead project resource planning, reforecasting, and program milestones.
• Manages a team (usually 3-6) working on a variety of routine and complex tasks
• Completes required work independently as well as managing work through direct reports
• Responsible for staffing assigned projects and for the professional development of direct reports.
• Makes recommendations to management on matters related to human resources, budget, and department operations
• Identifies, recruits, and hires functional staff
• Ensure that employees are appropriately trained, developed, and coached to comply with study requirements, company policies, and respective agency regulations
• Advocate for and drives timely completion of assigned goals and organizational changes within the organization
• Leads by example to create a positive work environment by encouraging mutual respect, accountability, smart risks, and innovation on a functional and project level.
• Offers help, support, and knowledge to drive for success across the organization and company (no silos)
• At least 30% of time spent managing others.
• Assure a climate of equal employment opportunity and promote an equitable workplace.
• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• B.S. degree in relevant scientific discipline or related field; advanced degree preferred
• 8 + years of clinical research experience, including at least 3-5 years of experience in managing clinical research in a leadership role.
• Established experience managing staff and setting department objectives
• Experience with lab operations and sample management is a plus.
• Experience and knowledge of oncology a plus.
• Experience with regulated in vitro diagnostic is a plus.
• Knowledge of applicable Regulations, and GCPs governing the conduct of clinical trials is required.

   

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to thrive and flourish in an entrepreneurial company environment requiring “hands-on” leadership.
• Physical and intellectual energy, a sense of urgency, and a strong work ethic.
• Learns and applies in-depth knowledge of Natera’s business and corporate objectives to analyze situations and available data in order to make effective plans to Sr. Management that are aligned with Natera’s goals and business objectives.
• Exercises solid and mature judgement to escalate issues in a timely manner.
• Keeps senior management apprised of business-critical risks and proactively develops comprehensive mitigation plans.
• Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations without damage to relationships.
• Provides feedback to both direct reports and management in a respectful and thoughtful way in order to achieve goals and deliverables aligned with departmental and corporate goals and objectives.
• Makes independent decisions pertaining to management and execution of assigned projects. Decisions made impact the Clinical Operations organization and Natera's expenditure of additional time, resources and/or funding.
• Expertise and current training in Good Clinical Practice (GCP).
• Strong project management, organizational and communication skills.
• Ability and willingness to travel at times with minimal advanced notice.
• Strong interpersonal skills and communication skills (both written and oral).
• Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
• Attention to detail, highly organized, with personal initiative. 
• Excellent team building and management skills.
• Excellent communication, conflict resolution, and follow-through skills.
• Results and goal oriented with willingness to roll up sleeves to achieve goals.
• Creative, strategic, flexible, and able to think “out of the box.”
• Proficient in MS Word, Excel, PowerPoint and clinical trial databases.
• Must have current GCP training

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• The ability to use a computer, communicate by telephone and read printed material is required.
• Duties may require working outside normal working hours (evenings and weekends) at times.

Travel required for this position:

No ☐  or Yes ☒ :  If yes state anticipated percent for travel: 15%