Senior Medical Director Nephrology
Senior Medical Director Nephrology
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
The Senior Medical Directorof Nephrology will be a key contributor to the Nephrology Program at Apellis. This position will have oversight of the clinical studies in C3G and ICMPGN and participate in clinical development activities for potential future indications. This individual will be responsible to lead interactions with regulatory agencies monitor clinical studies review and interpret clinical trial data author clinical study and regulatory communications.
Key Responsibilities Include:
- Serve as the clinical lead in interactions with regulatory agencies.
- Lead development of clinical study protocols.
- Provide sponsor medical oversight for nephrology clinical studies.
- Medical monitoring coding and data cleaning in collaboration with clinical operations and data management.
- Serve as the primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory safety and other functions.
- Lead the draft of clinical study reports.
- Author clinical sections of regulatory documents including not study protocols investigator brochures briefing documents annual updates and other studyrelevant documents such as patient informed consent documents.
- Supporting or preparing data interpretation and clinical trial reports.
- Acting as an internal resource for functions requiring clinical input and nephrology expertise.
- Write manuscripts publications or other documents intended for external audiences.
- Lead clinical advisory boards and support Medical Affairs as needed.
Education Registration & Certification:
- Must have a MD or DO degree (or international equivalent)
Experience:
- 8 years of experience clinical research phase III clinical trial experience is a plus.
- Must have prior experience in nephrology.
- Experience in interaction with different regulatory agencies and payers.
- Experience managing CROs.
- Experience initiating and managing or participating in clinical trials for industry.
- Experience presenting medical data and concepts to a variety of audiences (medical scientific vendors) in a credible and engaging manner.
- Strong technical/analytical skills to identify and solve problems.
- Selfmotivated assertive and selfconfident with the ability to act with urgency and passion.
- Proven ability to work with a high level of integrity accuracy and attention to detail.
- Ability to make thoughtful integrated timely and meaningful decisions and take corresponding actions.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships
- Proactively seek out and recommend process improvements.
- Entrepreneurial enjoys working in a fastpaced smallcompany environment.
- Demonstrated application of critical thinking skills.
- Proven ability to multitask prioritize and execute corporate objectives and goals.
- Ability to operate autonomously in a fastpaced early phase company.
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.
Travel Requirements:
- Up to 20 travel expected
Benefits and Perks:
Apellis offers a comprehensive benefits package including a 401(k) plan with company match inclusive family building benefits flexible time off summer and winter shutdowns paid family leave disability and life insurance and more! Visithttps://apellis/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop lifechanging 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 preclinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
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.
Required Experience:
Director
Employment Type
Full Time
