Apellis Pharmaceuticals
Senior Director, Clinical Science
Apellis Pharmaceuticals, Waltham, Massachusetts, United States, 02254
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Senior Director, Clinical Science
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Apellis Pharmaceuticals . Summary
The Sr. Director, Head of Clinical Science, is a key member of our clinical development team and is a major contributor to the development and execution of the clinical strategy for our clinical development programs. The successful candidate will interface with the entire clinical team to provide scientific expertise, and will also have opportunities to make strategic and scientific impacts on current and future clinical programs. Roles And Responsibilities
Establishes the clinical science competency built on a positive organizational culture grounded in clinical scientific expertise. Manages a team of Clinical Scientists (across all levels), ultimately responsible for leading multidisciplinary teams in the design, planning, execution, and interpretation of clinical development plans across all stages of development. Represents Clinical Development in leadership and governance meetings/committees. Partners with therapeutic area Medical Directors and R&D colleagues to advance drug development, clinical design strategy, and program prioritization across R&D portfolio of programs. Leads and supports cross-functional clinical development teams, represents clinical development on program teams and liaises as needed with project teams. Builds credible relationships with external partners (e.g., principal investigators, key opinion leaders) and represents the company to relevant health authorities and consultant/advisory meetings. Builds and manage a strong Clinical Scientist team with responsibility for establishing the team strategy, resource planning, talent development and management. Performs Clinical Scientist responsibilities on key programs as needed. Remains up to date on current regulations, guidelines, and scientific advances relevant to Apellis. Facilitates cross-functional collaboration with Translational Medicine to transition research stage assets to clinical development. Manages Clinical Scientists in the timely and thorough review of study data using best practices and available tools to identify and evaluate trends. Participates in due diligence activities as requested. Leads non-study cross functional activities or initiatives. Travel to field sites, internal and external meetings and conferences as needed. Education, Registration & Certification
MD/OD/PhD in related life science discipline preferred, with relevant clinical development experience. Experience
8+ years of clinical development in the pharmaceutical/biotech industry including multiple years in a leadership role. Previous experience in drug development is required. Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. Experience interacting with clinical investigators and medical experts. Knowledge, Skills, And Abilities
Demonstrated ability to effectively lead, influence and manage within a highly matrixed organization. Have and maintain the expertise necessary for clinical development of pharmaceutical products. Capable of analyzing and interpreting clinical study results and providing guidance in the preparation of high quality study reports. In conjunction with Medical Writing, responsible for protocol synopses, protocol development, clinical study reports and other relevant clinical documents. Proven teamwork skills with established success operating efficiently and collaboratively in multidisciplinary teams. Deep expertise of the multidisciplinary drug development, clinical study design & execution, and ability to proactively integrate cross-functional perspectives into the clinical development process. Ability to distill complex scientific information, highly effective in presenting, communicating, and discussing scientific/medical topics across audiences. In depth knowledge of the global clinical development process, clinical trial requirements, study design, regulatory process and lifecycle management. Demonstrated ability to impact Clinical Development effectiveness using well-developed conflict resolution skills. Able to positively influence change and drive organizational alignment. Ability to effectively manage, develop, and motivate others. Highly organized, results driven, problem solver with ability to synthesize, organize, manage, and communicate safety data from various sources. Superior written and oral communication skills and the ability to work collaboratively and build relationships with colleagues from different levels of the organization. Highly motivated with the ability to be flexible in a fast-paced environment. Proven track record of leadership and people management. Travel Requirements
Up to 30% travel (domestic and international). Education
Doctorate Degree. Pay Information
Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $242,000-$363,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions. 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! Visit https://apellis.com/careers/benefits/ to learn more. Company Background
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. 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.
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Senior Director, Clinical Science
role at
Apellis Pharmaceuticals . Summary
The Sr. Director, Head of Clinical Science, is a key member of our clinical development team and is a major contributor to the development and execution of the clinical strategy for our clinical development programs. The successful candidate will interface with the entire clinical team to provide scientific expertise, and will also have opportunities to make strategic and scientific impacts on current and future clinical programs. Roles And Responsibilities
Establishes the clinical science competency built on a positive organizational culture grounded in clinical scientific expertise. Manages a team of Clinical Scientists (across all levels), ultimately responsible for leading multidisciplinary teams in the design, planning, execution, and interpretation of clinical development plans across all stages of development. Represents Clinical Development in leadership and governance meetings/committees. Partners with therapeutic area Medical Directors and R&D colleagues to advance drug development, clinical design strategy, and program prioritization across R&D portfolio of programs. Leads and supports cross-functional clinical development teams, represents clinical development on program teams and liaises as needed with project teams. Builds credible relationships with external partners (e.g., principal investigators, key opinion leaders) and represents the company to relevant health authorities and consultant/advisory meetings. Builds and manage a strong Clinical Scientist team with responsibility for establishing the team strategy, resource planning, talent development and management. Performs Clinical Scientist responsibilities on key programs as needed. Remains up to date on current regulations, guidelines, and scientific advances relevant to Apellis. Facilitates cross-functional collaboration with Translational Medicine to transition research stage assets to clinical development. Manages Clinical Scientists in the timely and thorough review of study data using best practices and available tools to identify and evaluate trends. Participates in due diligence activities as requested. Leads non-study cross functional activities or initiatives. Travel to field sites, internal and external meetings and conferences as needed. Education, Registration & Certification
MD/OD/PhD in related life science discipline preferred, with relevant clinical development experience. Experience
8+ years of clinical development in the pharmaceutical/biotech industry including multiple years in a leadership role. Previous experience in drug development is required. Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies. Experience interacting with clinical investigators and medical experts. Knowledge, Skills, And Abilities
Demonstrated ability to effectively lead, influence and manage within a highly matrixed organization. Have and maintain the expertise necessary for clinical development of pharmaceutical products. Capable of analyzing and interpreting clinical study results and providing guidance in the preparation of high quality study reports. In conjunction with Medical Writing, responsible for protocol synopses, protocol development, clinical study reports and other relevant clinical documents. Proven teamwork skills with established success operating efficiently and collaboratively in multidisciplinary teams. Deep expertise of the multidisciplinary drug development, clinical study design & execution, and ability to proactively integrate cross-functional perspectives into the clinical development process. Ability to distill complex scientific information, highly effective in presenting, communicating, and discussing scientific/medical topics across audiences. In depth knowledge of the global clinical development process, clinical trial requirements, study design, regulatory process and lifecycle management. Demonstrated ability to impact Clinical Development effectiveness using well-developed conflict resolution skills. Able to positively influence change and drive organizational alignment. Ability to effectively manage, develop, and motivate others. Highly organized, results driven, problem solver with ability to synthesize, organize, manage, and communicate safety data from various sources. Superior written and oral communication skills and the ability to work collaboratively and build relationships with colleagues from different levels of the organization. Highly motivated with the ability to be flexible in a fast-paced environment. Proven track record of leadership and people management. Travel Requirements
Up to 30% travel (domestic and international). Education
Doctorate Degree. Pay Information
Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $242,000-$363,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions. 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! Visit https://apellis.com/careers/benefits/ to learn more. Company Background
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. 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.
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