Sr. Manager, Medical Affairs Evidence Generation & Strategic Operations

Job Description

Job Description

Position Summary :

The Medical Affairs Evidence Generation and Strategic Operations Sr. Manager, is a key member of the Global Medical Strategy and Evidence Generation team who will work closely with Medical Affairs and cross-functional stakeholders in

executing project management and operational activities for key initiatives of the global strategy and evidence generation plan for systemic pegcetacoplan.

The successful candidate will lead operations for Real World Evidence (RWE) studies

non-interventional and observational studies) with additional focus on publication and strategic initiative operations.

Key Responsibilities Include :

Evidence Generation Operations

Project Management : Lead project management and day to day operations and tracking of ongoing evidence generation efforts i.

e. phase IV and observational studies according to the Global Evidence Generation Plan. Manage information and communications from vendors to inform and support team decision making, including updates / presentations.

Coordinate and prepare deliverables for internal review processes and document archiving. Proactively manage changes and / or variance in scope, budget, expected milestones / deliverables.

Develop and optimize operational efficiencies. Manage external vendors (i.e. guidance with vendor selection i.e. operational review of proposals , quality oversight of vendors i.

e. vendor qualification, contract review and execution, compliance with applicable SOPs , coordination of communication and deliverable transfers between vendor and company)

Study level responsibilities : Ensure evidence generation projects are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements.

Assist in study team coordination and updates to cross functional partners including clinical development, pharmacovigilance and regulatory as related to non-interventional and observational evidence generation

Publication and Strategic Operations

Publication Operations : Manage medical writing vendor to ensure execution of publication plan in accordance with timelines are met along with adherence to budget.

Contribute to the development of the Publication and Communications Strategic Plan for systemic pegcetacopan, including support of data generation and communication planning.

Support development of high-visibility scientific presentations i.e. abstracts, posters, slides , manuscripts, and Medical Affairs field team resources i.

e. training materials, medical briefs, Q & As to share ground-breaking new clinical and RWE data while ensuring compliance with all relevant guidelines, laws, and industry standard best practices.

Strategic Operations : Operational and planning support of medical conferences, advisory and / or scientific steering committee meetings.

Budget tracking and reconciliation support.

Education, Registration & Certification :

Must have a bachelor's degree.

A master's degree MPH, MS, MA in a health-related or life sciences field with PMP certification are preferred.

Experience :

• 3 years + project and / or vendor management experience in pharmaceutical / biotechnology supporting cross-functional teams
• Vendor management experience
• Experience in interventional, non-interventional or observational clinical study operations or medical affairs preferred

Skills, Knowledge & Abilities :

• Strong project management and tracking skills, including demonstrated ability to manage multiple projects
• Proficiency in project management software i.e. Smarsheet, OnePager , Microsoft office suite, OneNote and Box
• Experience in Datavision preferred
• Excellent oral and written communication skills, including presentation and facilitation
• Strong cross-functional collaboration skills
• Ability to work independently and with flexibility to handle workflow in a fast-paced environment

Travel Requirements :

Some travel will be required, up to 30%

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 https : / / apellis.

com / careers / to learn more.

Company Background :

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face.

We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world.

With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http : / / apellis.com or follow us on Twitter and LinkedIn

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 pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings : Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

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.