Sr. Director, Development Lead Waltham, Massachusetts, United States
19 Days Old
Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.
Apellis is seeking an experienced and visionary Senior Director, Development Lead to serve as the lead and sole representative from Research & Development (R&D) for one or more cross-functional strategy teams. This senior leadership role will be responsible for providing strategic direction and scientific guidance for R&D activities from ideation through life-cycle management, with a direct impact on the success of key programs and the overall company.As the Development lead, the Senior Director will work closely with senior leaders from Commercial, Technical Operations, Medical, and Corporate Strategy to ensure alignment on key objectives and the seamless integration of R&D strategies across the drug development process. This role will champion the R&D perspective, offering expert scientific and drug development insights while ensuring that R&D activities align with business and regulatory objectives.
The individual will leverage their extensive expertise in drug development to shape the program’s scientific vision, foster innovation, and ensure the efficient and successful progression of programs through clinical development and regulatory approval.Reporting to the Head of Clinical Development, this highly visible role requires a proven leader who can influence and align diverse teams, manage complex projects, and navigate the dynamic and evolving landscape of drug development.
Key Responsibilities Include:
Act as the sole representative of R&D on one or more cross-functional strategy teams, ensuring that R&D priorities and strategies are aligned with business and regulatory goals throughout the development process.
Provide strategic oversight for R&D activities, including drug discovery, preclinical research, and clinical development, ensuring they align with the company’s long-term objectives.
Drive the development of Integrated Asset Plans, Target Product Profiles, Regulatory Strategies, and Lifecycle Management Strategies, integrating the R&D perspective to support the broader strategy.
Serve as the primary conduit between R&D and other key functions (Commercial, Technical Operations, Medical, Corporate Strategy) to ensure consistent communication and alignment on program direction and execution.
Ensure the R&D strategy supports timely and effective regulatory submissions to facilitate product development and approval.
Lead R&D decision-making within the strategy team, contributing to the development and refinement of program strategies, including clinical trial design, regulatory submissions, and lifecycle management.
Identify and proactively address potential risks or obstacles that could impact the development timeline or program success, collaborating with functional leads to mitigate issues effectively.
Scientific Expertise & Guidance: Provide expert scientific guidance across all stages of drug development, ensuring the design and execution of research and clinical strategies are scientifically rigorous and aligned with company goals.
Shape the scientific direction for one or more programs, staying informed on emerging scientific trends and ensuring the integration of innovative approaches into development plans.
Serve as the internal and external scientific expert on assigned programs, providing in-depth knowledge of the disease indications, treatment landscapes, and drug development strategies.
Provide mentorship and guidance to R&D team members, fostering a culture of scientific excellence, accountability and continuous improvement.
Serve as a key resource for the broader organization, offering deep scientific and technical expertise in drug development to elevate enterprise thinking and capabilities of drug development.
Contribute to the evaluation of R&D talent, ensuring the team remains at the forefront of scientific innovation and industry best practices.
Contribute to the evaluation of new technologies, scientific platforms, and therapeutic approaches that align with the company's strategic objectives.
Provide scientific input into the business development opportunities, including partnerships, licensing agreements, and acquisitions within the relevant therapeutic areas.
Play an integral role in shaping the scientific vision and future direction of the company through one or more key programs, including identifying emerging scientific trends and new opportunities for innovation.
Education, Registration & Certification:
Bachelor's degree in Life Sciences required, advanced degree in Life Sciences (PhD, MD, M.Sc., Pharm.D., or equivalent) preferred
Experience:
At least 10 years of drug development experience in the biotech or pharmaceutical industry, with a minimum of 5 years in leadership roles within R&D.
Extensive experience in scientific leadership and deep expertise across the entire drug development lifecycle, from early-stage research through clinical development and regulatory submission.
Proven track record in leading scientific strategy, clinical trial design, and regulatory submissions in a cross-functional environment.
Expertise in developing and executing innovative scientific strategies and ensuring their alignment with company goals across preclinical and clinical stages.
In-depth experience in identifying scientific opportunities and challenges, particularly in translating complex scientific data into actionable development plans.
Skills, Knowledge & Abilities:
Scientific Expertise: Deep knowledge of drug discovery and development processes, including preclinical research, clinical development, regulatory strategies, and lifecycle management as well as pharmacology, toxicology, formulation science, and biostatistics. Ability to provide high-level scientific guidance across various therapeutic areas, with a strong focus on ensuring scientific rigor in program execution.
S trategic Oversight: Ability to integrate scientific insights into strategic development decisions, including clinical trial design, regulatory strategies, and market entry planning.
Expertise in Regulatory Pathways: Strong understanding of the regulatory landscape, including experience with IND/CTA submissions, clinical trial design, and global regulatory requirements.
Communication: Exceptional ability to communicate complex scientific concepts and data to both technical and non-technical stakeholders, ensuring alignment across functional teams and leadership. Strong executive presence with the ability to influence individuals at all levels.
Innovation & Trends: Proven ability to identify emerging scientific trends, technologies, and therapeutic approaches that can inform development strategies and enhance the drug development pipeline.
Cross-functional Collaboration: Proven success in leading scientific discussions and aligning R&D strategies across functions, ensuring scientific objectives are met while supporting broader business goals.
Problem-Solving & Decision-Making: Strong critical thinking and problem-solving skills, with the ability to synthesize scientific data and address technical challenges in a timely and effective manner.
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. 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.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.
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.
Apply for this job *
indicates a required field
First Name *
Last Name *
Email *
Phone *
Resume/CV *
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
Enter manually
Accepted file types: pdf, doc, docx, txt, rtf
LinkedIn Profile
Are you willing to relocate? * Select...
Will you now or in the future require work sponsorship? * Select...
Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.
As set forth in Apellis’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Select...
Voluntary Self-Identification of Disability Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026
Voluntary Self-Identification of DisabilityForm CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Find out more about this role by reading the information below, then apply to be considered.
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .
How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
Note to Employment Agencies: Please do not forward any agency resumes. Apellis is not responsible for any fees related to resumes that are unsolicited.
#J-18808-Ljbffr
- Location:
- Waltham, MA
- Salary:
- $150
- Category:
- Management And Consultancy