Executive Director, Clinical Development
SystImmune
Job Description
\nLead the direction, planning, execution, and interpretation of clinical trials within the Clinical Development program. Collaborate across functions to deliver high-quality clinical data that supports product development, regulatory submissions, and business strategy.
\n \nJob Summary
\n- \n
- Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives. Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs. \n
- Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements. \n
- Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages. \n
- Serve as the medical lead on clinical study teams , aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements. \n
- Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums. \n
Qualifications :
\n- \n
- M.D. or equivalent (international degrees accepted). \n
- Minimum of 2 years of experience in medical monitoring of oncology clinical trials; phase 1/2 required, phase 3 experience preferred. \n
- Prior experience in clinical development or pharmaceutical/biotech settings. \n
- Proven track record in product safety oversight and clinical trial execution, particularly with biologics such as ADCs and immune-oncology agents. \n
- Strong foundation in clinical and drug development processes. \n
- Sound medical judgment with expertise in medical safety data interpretation. \n
Vacancy posted 9 days ago
Similar jobs that could be interesting for youBased on the Executive Director, Clinical Development in Princeton, NJ vacancy
- ...Lead the direction, planning, execution, and interpretation of clinical trials within the Clinical Development program. Collaborate across functions to deliver high-quality clinical data that supports product development, regulatory submissions, and business strategy....Suggested
$333k - $416.4k
...Executive Director, Clinical DevelopmentThe Executive Director, Clinical Development will be a highly qualified and motivated individual who will have a supporting leadership role in the development of Acadia programs for neuropsychiatric disorders and rare disease. This...SuggestedWork at officeLocal areaRemote workNight shift- ...Otsuka is seeking a Director, Global Clinical Development (GCD) based Remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices...SuggestedRemote workWeekend work
$265k - $295k
..., we use our TransCon® drug development platform to fulfill our mission... ...skills. The Medical Director is involved in the design, monitoring... ...of the Company’s late-phase clinical trials in endocrinology. As... ...clinical trial design and execution Strong track record of...SuggestedTemporary workFlexible hours$240k - $300k
...Washington. Company Overview: SystImmune Inc. is a dynamic clinical-stage bio-pharmaceutical company headquartered in Redmond, WA.... ...salary and benefits package Opportunities for professional development and career advancement Work in a dynamic and collaborative...SuggestedFull timeContract workWork at office2 days per week3 days per week$200k - $300k
...Regulatory Affairs (Clinical/Nonclinical)SystImmune is a leading... ...using its established drug development platforms, focusing on bi-specific... ...regulatory strategy and execution within SI Project development... ...role could range across Director/Sr. Director/Exec Director based...$323.85k - $381k
...also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we... ...evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other...Local area$306.1k - $382.6k
...days per week. Position Summary Join Acadia as a Senior Director, Clinical Development and play a key leadership role in advancing innovative therapies... ...clinical development programs, guiding strategy, study execution, and regulatory interactions. You will partner with...Work at officeLocal areaRemote workNight shift3 days per week$209.6k - $313.38k
...Overview APC-GCD (Otsuka Pharmaceutical Development & Commercialization, Inc.) is hiring an Associate Director/Director/Senior Director for Global Clinical Development in Rockville, MD or... ...Accountability for results and strategic execution. Strategic thinking and problem...Temporary workWork at officeFlexible hours- Acadia Pharmaceuticals is seeking a Director of Clinical Development to lead global clinical development plans for neuropsychiatric and rare disease programs. You will shape strategies, collaborate with internal and external stakeholders, and advance programs from early...3 days per week
$209.6k - $313.38k
...Director, Global Clinical Development Within Otsuka Pharmaceutical Co. exists Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) a U.S.A. subsidiary that includes the Global Clinical Development (GCD) department. OPDC-GCD are a group of physicians and...Temporary workLocal areaFlexible hoursWeekend work$235k - $255k
...biopharmaceutical company focused on development and commercialization of innovative medicines... ...facility for an experienced R&D/Clinical Quality leader to oversee our small QA... ...commensurate with experience.The Senior or Executive Director, Research and Development Quality...Full timeContract workWork at officeLocal area$261.63k - $317.03k
...Bristol Myers Squibb seeks an Executive Director to lead integrated procurement for Product Development, Analytical Services, and Direct Materials, managing approximately $1B in annual spend across the product lifecycle. The role requires establishing unified category...$210k - $225k
...Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new... ...employees to grow and develop their skills.The Director of Systems, Quality, and Training supports the Clinical Development team and collaborates closely with our...Temporary workFlexible hours$302k - $335k
...disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients,... ...unites our efforts. Learn more at .Summary:The Senior Medical Director, Clinical Science is a vital position in our growing global...Summer workLocal areaWorldwide2 days per week$180k - $230k
...SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located... ...cancer treatments using its established drug development platforms, focusing on bi-specific,... ...compounds Author components with the Medical Director and reviewer of clinical and regulatory...Full time$297.59k - $360.6k
...Bristol Myers Squibb seeks an Executive Director to lead the Clinical Design and Delivery Center, overseeing protocol review, clinical development training programs, and process innovation across the organization. The role combines strategic leadership of the Protocol...Work at office- ...Senior Director, Clinical PharmacologyKardigan is a heart health company working to make cardiovascular... ...to the Vice President, Early Development, the Senior Director, Clinical Pharmacology... ...be responsible for establishing and executing clinical pharmacology strategies from...
- ...Title: Practice Manager / Clinic Director Location: Princeton Junction, NJ Join an established - and growing - organization as Kaleidoscope... ...regarding business operations, business growth and development, staff scheduling, personnel management, customer acquisition...Weekly payFull timeWork experience placementWork at office
- ...FPC of Greensboro has partnered with MAIA Pharmaceuticals in its search for a Director of Analytical Development . MAIA is a specialty pharmaceutical company with a team of 90+ R&D professionals tackling complex formulation and drug delivery challenges to improve...Remote work
- ...Based Education: Bachelors Degree Title: Practice Manager / Clinic Director Location: Princton Junction, NJ Join an established - and growing... ...regarding business operations, business growth and development, staff scheduling, personnel management, customer acquisition...Weekly payWork experience placementWork at office
$220k - $280k
...is a leading and well-funded clinical-stage biopharmaceutical... ...using its established drug development platforms, focusing on bi-specific... ...and motivated Senior Global Director, Clinical Project Management... ...Oversee the planning and execution of global clinical trials...Full timeWork at officeLocal areaNight shift- ...FPC of Greensboro has partnered with MAIA Pharmaceuticals in its search for a Director of Product Development . MAIA is a specialty pharmaceutical company with a team of 90+ R&D professionals tackling complex formulation and drug delivery challenges to improve patient...Remote work
- Bristol Myers Squibb Co in Princeton, NJ is seeking a Director, Clinical Pharmacology to lead CP&P strategies across development programs, reporting to Senior Director. You will apply PK/PD and model-informed drug development to support decision-making, shape integrated...
- ...A leading global contract services provider is seeking an accomplished Executive Director/VP Quality and Regulatory to oversee Quality Assurance and Regulatory Affairs functions. This role requires deep expertise in global regulatory compliance, strong leadership skills...Full timeContract work
- Company DescriptionAbout Client: They are an equal opportunity employer and with value diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability...
$290k - $350k
...Executive Director, Global Medical Affairs Lead - Oncology Reports to: SVP, Head of Clinical Development and Medical Affairs Location: Remote Position Overview: The Executive Director, Global Medical Affairs Lead will be responsible for developing and executing...Full timeRemote work$157.36k - $236.04k
...Then we would love to have you join us! Position: Associate Director, Clinical Data ManagementDepartment: Clinical Data Integration and... ...oversight and consistency across the trials within one or more development projects. The DM Lead will provide asset-level DM expertise...Full timeFixed term contractLocal area- ...Executive Director, Global Medical Operations About the Company Internationally renowned... ...work pharmaceuticals research and development and healthcare Business... ...in both drug development and medical/clinical study operations. The role requires a...Local area
- ...company pioneering the discovery and development of small molecule therapies targeting... ...in oncology. Position Summary The Executive Director, Market Access will lead the development... ...functionally with Commercial, Medical Affairs, Clinical Development, Regulatory, Finance,...Remote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Executive Director, Clinical Development. Be the first to apply!
Related searches
- chief of psychiatry Princeton, NJ
- restaurant managing partner Princeton, NJ
- technology executive Princeton, NJ
- executive security Princeton, NJ
- executive support Princeton, NJ
- executive functioning Princeton, NJ
- managing director Princeton, NJ
- board member Princeton, NJ
- talent acquisition executive Princeton, NJ
- human resources executive Princeton, NJ




