Senior Director, Medical and External Affairs

Job Locations US-IL-LAKE FOREST
ID
2020-1117
Category
Management
Type
Regular Full-Time

Overview

Responsible for Medical and External Affairs and will be part of the R&D leadership team. In addition, this position will closely partner with the Clinical Affairs and Regulatory departments in the design of clinical studies responsible for developing and executing the medical and external affairs strategy, overseeing the Medical Science Liaison team and the Advocacy/External Affairs function playing a lead role in the design of clinical trials and clinical development programs, in line with departmental and corporate goals. 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 Assertio.

 

Also responsible for executing and managing pharmacovigilance activities that include adverse event reporting, safety assessments, signal detection and aggregate reporting in compliance with applicable FDA and global regulations and Assertio standard operating procedures and guidelines.

 

Externally work with business partners to ensure execution of contracts that include, but are not limited to, safety vendor/s and companies.

 

Assist with the preparation of internal and external reports (e.g. PADERs) and production and distribution of routine pharmacovigilance metrics. Help drive internally, and collaborate with external partners, in the development and execution of risk management activities including Risk Evaluation and Mitigation Strategies (REMS) programs. Collaborates on projects and activities to support Assertio’s REMS programs.

Responsibilities

  • Responsible for the design of clinical development programs, incorporating input from the VP, Clinical Development, the broader clinical team, and external advisors
  • Responsible for designing specific Phase 1-4 clinical trials with objectives that range from product development to post-marketing commitments
  • Review submissions to FDA made on behalf of Assertio for clinical accuracy, completeness and consistency
  • Work with Clinical Ops to draft and finalize Safety Management Plans
  • Direct vendor in signal detection activities
  • Review adverse event information received by Pharmacovigilance vendors for clinical accuracy, completeness and consistency
  • Reviews case information for appropriate distribution to internal and external business partners
  • Assists in the compilation of individual and aggregate reports (PADERs, etc.) per U.S. regulations
  • Act as primary point of contact for safety reporting in ongoing trials
  • Act as a liaison with internal departments and external business partners on Drug Safety and Pharmacovigilance operation management issues and clinical study related activities
  • Guide and provide expertise to the vendors in Pharmacovigilance and clinical studies
  • Work with the Government Affairs function to ensure that Assertio leadership is informed on state and federal level initiatives and be responsible for developing and implementing medical and scientific strategies
  • Oversight of the Advocacy & External Affairs function, with the goal of establishing this function as a key support and operational function within the company
  • Oversight of the MSL organization to provide strategic leadership to this team
  • Develop and execute the medical KOL strategy, coordinating with the commercial and compliance organizations to ensure a coordinated approach to these key stakeholders.
  • Design and oversee the execution of HEOR studies that will be the basis for discussions with payors and other key stakeholders.
  • Partner with Clinical Regulatory Affairs on key aspects of clinical strategy
  • Take the lead on the design of clinical trials that specifically impact product scheduling or product labelling.
  • Oversight of “Investigator Initiated Trials” strategy and grants

Qualifications

Education/Experience

  • M.D. degree is required with 5+ years of experience in clinical trial design and pharma clinical development
  • Some expertise in clinical development
  • Demonstrated ability, or potential, to excel in smaller entrepreneurial organizations
  • Impressive, consistent and recent track record of success and achievement
  • Experience in Pharmacovigilance & Risk Management
  • Experience in phases I-IV drug safety surveillance
  • Proficient in MedDRA coding of medical terminology and WHO-DD drug classification
  • Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
  • Experience with preparation of investigational and post-marketing regulatory reports

Skills and Abilities

  • Demonstrated expertise in clinical study design and pharmacology
  • Demonstrated 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.
  • Proven ability to critically evaluate and summarize clinical and scientific data
  • Highly organized and demonstrates consistent attention to detail
  • Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills
  • Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • 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.
  • 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

Physical Requirements

  • Ability to operate a motor vehicle
  • Ability to travel via airplane
  • Ability to sit for long periods of time
  • Ability to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal.
  • Reaching: Extending hand(s) and arm(s) in any direction.
  • Standing: Remaining upright on the feet.
  • Pushing: Using upper extremities to press against something with steady force in order to thrust
  • Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position of up to 20 lbs. on occasion

 Mental Requirements

  • Ability to prepare and analyze data and figures
  • Ability to understand, remember and apply oral and written instructions
  • Ability to organize and prioritize own works schedule
  • Ability to apply common sense in performing job
  • Ability to understand and follow instructions

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

 

For more information about your EEO rights as an applicant under the law, please click here.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed