Senior Director, Safety Surveillance & Risk Management

Clinical Waltham, Massachusetts


Description

Position Summary:

The senior director is a member of our safety & pharmacovigilance leadership team and is responsible for global signal detection and evaluation, as well as safety risk management. Reporting to the VP, Safety & Pharmacovigilance, this role will be accountable for ensuring safe investigational and commercial use of Apellis products, and providing accurate information to prescribers, patients and regulators. S/he will also lead the US REMS team, the Medical Review Team, and be a member of the US launch team. S/he will work with the EU QPPV to ensure that identified signals are managed and tracked in accordance with GVP, and work with clinical development and medical affairs colleagues to ensure an integrated approach to safety risk management throughout the company. An additional responsibility will be the development and maintenance of signal detection procedures using Apellis-licensed technology.

Key Responsibilities Include:

  • Lead the US REMS team, REMS system procurement, oversight and periodic reporting
  • Chair the medical review team (MRT), and ensure periodic data review across the product development program
  • Responsible for the clinical and post-marketing surveillance of Apellis products, employing regular evaluation of internal and external safety information
  • Provide drug safety expertise and guidance to cross-functional program and launch teams
  • Implementation of risk management plans in accordance with regulatory and license requirements
  • Ensure timely identification and evaluation of safety signals from all information sources, and appropriate escalation to the medical governance committee
  • Evaluate benefit-risk of products in partnership with other clinical leaders
  • Recruit and manage safety scientist/physician(s)
  • Provide draft safety language for prescriber/patient information in partnership with regulatory affairs, and in collaboration with the EU QPPV for European labelling
  • Member of the regulatory application filing team(s), contributing to the common technical document and responses to questions
  • Represent Safety & PV at Data Monitoring Committee meetings
  • Participate in the selection of vendors, technology and consultants
  • Ensure accurate and appropriate safety language in GCP documents
  • Review and approve periodic safety reports, together with the EU QPPV
  • Support due diligence activity
  • Other duties as assigned

Education, Registration & Certification:

  • MD, PhD, PharmD, MPH or DVM is required

Experience:

  • At least 12 years of industry pharmacovigilance and safety risk management experience required, including experience with specialty care products
  • REMS program experience is required
  • NDA/MAA filing experience is required
  • Line management experience is a strong advantage but is not essential

Skills, Knowledge & Abilities:

  • Comfortable working independently with minimal supervision 
  • Proven record as a subject matter expert
  • Able to lead a multi-disciplinary team comprising members with diverse functional expertise
  • Highly organized, results driven, problem solver with a global outlook
  • Superior written and oral communication skills, and the ability to work with different levels of management 
  • Thorough knowledge of GCP, GVP, regulatory guidelines on PV
  • Extensive knowledge of MedDRA and PV databases
  • Highly motivated with the ability to be flexible in a fast-paced environment 
  • Experience with signal generation science and tracking technology is an advantage
  • Able to represent the company in a professional manner, both verbally and in writing
  • Occasional regional and international travel will be required

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

 

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.