Assertio Therapeutics, Inc.

Sr. Director, Clinical Affairs

Location
Lake Forest, IL, United States
Posted
Jul 25, 2018
Ref
1069XX
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Responsible for clinical trial strategy, and all clinical deliverables. Plays a lead role in clinical development programs including the design, implementation and execution of clinical trials and, in line with departmental and corporate goals. Responsible for clinical deliverables as they relate to regulatory submissions and functioning as the clinical representative for regulatory interactions. Works closely with other functions such as CMC, QA, Medical Affairs and Regulatory to ensure quality, timely and coordinated clinical study activities in compliance with the appropriate GCP/ICH and health authority guidelines. Plays a key role in supporting business development activities at Depomed. Represents the company at appropriate academic, industry, medical and regulatory meetings.

ESSENTIAL JOB FUNCTIONS
  • Responsible for clinical leadership for sNDAs, NDAs and other regulatory submissions
  • Responsible design of design, implementation and execution of clinical development programs, incorporating input from the cross-functional team and external advisors
  • Responsible for designing specific Phase 1-4 clinical trials with objectives that range from product development to post-marketing commitments to supporting publications
  • Oversight of biostatistics, deploying internal and external resources in support of the clinical studies, HEOR studies, etc.
  • Oversight of the Drug Safety function at Depomed
  • Represents the Clinical Affairs organization within the Business- and Corporate-Development Teams
  • Participates at numerous national and regional conferences, meetings and other scientific venues


Requirements

EDUCATION AND EXPERIENCE
  • Pharm.D, M.D. and/or PhD degree is required
  • Expertise in clinical development with >5y of experience in clinical development
  • Experience leading drug safety function
  • Demonstrated ability, or potential, to excel in smaller entrepreneurial organizations
  • Strong business acumen
  • Impressive, consistent and recent track record of success and achievement
  • Ability to travel up to 30%


SKILLS AND ABILITIES
  • Demonstrated leadership skills and ability to manage complex processes and initiatives
  • Experience and the desire to work within a fast-paced department is required
  • Action-oriented with strong sense of urgency; responsive to others; meets service expectations of others
  • Proven ability to operate independently, be resourceful and exercise astute business judgment to drive performance.
  • Excellent interpersonal, verbal and written presentation skills.
  • Demonstrated experience in segmentation, targeting, and positioning to successfully drive growth.
  • Strong analytical and qualitative skills and ability to synthesize and integrate customer insights data, draw conclusion and implications, and translate into comprehensive strategies and business decision recommendations.
  • Ability to translate Strategy to Tactics.
  • Cross-Functional Leadership and Stakeholder Management experience
  • Results driven; highly organized with strong ability to follow through, prioritize and execute agreed upon plans without supervision
  • Strong knowledge of Microsoft Word, Excel, and PowerPoint
  • Excellent organizational and time management skills


DEPOMED COMPETENCIES INCLUDE
  • Decisions and Judgment: independently completing assigned tasks by gathering relevant information systematically and considering a broad range of issues or factors when making decisions.
  • Ownership and Initiative: Assumes personal ownership and accountability for business results and solutions. Organizes work based on company/department goals. Develops alternative strategies when confronted with obstacles. Plans and organizes work so that timelines are met or exceeded.
  • Communication skills: Expresses ideas and information effectively and constructively. Provides accurate and timely information to others within the department and across functional groups. Demonstrates attention to and understanding of others' comments, questions, and views.
  • Leadership: Articulates a clear direction and demonstrates the ability to motivate and positively influence others. Effectively manages people, projects, and budgets. Clearly defines performance standards for employees and gives recognition when appropriate. Ensures employees have clear measurable goals aligned with organization's priorities and holds people accountable for results. Addresses performance and behavior issues in a timely manner. Inspires people to excel by modeling excellence and enthusiasm. Empowers teams to solve problems and initiate improvements. Identifies organizational needs and attracts, selects and retains talent.


OTHER REQUIREMENTS
  • Ability to direct the day-to-day work of others and the ability to recruit, develop and retain high performing employees.
  • Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
  • Ability to organize and prioritize work schedules of others on a long-term basis
  • Ability to make decisions which have significant impact on the Company's reputation, credibility, operations and services.
  • Ability to formulate complex and comprehensive materials such as legal documents, authoritative reports, official publications and make formal presentations.


About Us

THE COMPANY

Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth:

MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed has relocated its headquarters to Lake Forest, Illinois.

Depomed is an AA/EEO/Veterans/Disabled employer.