Senior Director, Clinical Development - United States
20 hours ago
Job description
Overview
Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology.
The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc.
Responsibilities
Preclinical and Translational Development
- Provide clinical and translational leadership to preclinical oncology programs
- Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans
- Contribute to the design, interpretation, and integration of:
- In vitro and in vivo efficacy models
- PK/PD and biomarker strategies
- Translational endpoints to support dose selection and first-in-human studies
- Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology
- Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials
- Participate in portfolio and pipeline discussions, including evaluation of new oncology targets or assets from a clinical and translational perspective
Clinical Development
- Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data
- Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel
- Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making
- Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
- Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data
- Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts
- Interface with regulatory agencies for clinical development programs and regulatory submissions as needed
- Oversee scientific interactions with medical consultants, advisors, and clinical investigators
- Establish and maintain strong relationships with clinical investigators and key opinion leaders, fostering enthusiasm and engagement for SKLSL programs
General
- Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development
- Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development
- Experience interacting with FDA and other global health authorities preferred
- Reports to the Chief Scientific Officer
Skills
- Evidence of ability to work with opinion leaders
- Must be able to work effectively in a team setting
- Communication skills necessary to:
- Represent the Company externally in scientific presentations, conferences and industry groups;
- Present to internal stakeholders; Interact with industry
Qualifications
- M.D. degree with specialized training in oncology preferred
- Practice experience preferable but not required
- Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience
- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Adapts change, adjust change and grasps information quickly
- Examine and observe details
Similar jobs
Imagene AI is seeking a pharma-experienced oncology leader to guide the clinical strategy behind our multimodal foundation model and its application across drug development. · This enables forecasting of key late-phase metrics and increases confidence in program prioritization an ...
4 weeks ago
The Clinical Sales Development & Enablement Consultant plays a critical role in equipping our sales organization with the skills, · clinical selling acumen, tools, and processes needed to drive growth, · strengthen customer relationships, · and align our approach with the evolvin ...
3 days ago
Overview · Clinical Business Developer · The Clinical Business Developer plays a pivotal role in establishing new clinical partnerships to support the launch and expansion of allied health and nursing programs. This position is dedicated to securing affiliation agreements with cl ...
1 week ago
· Make your mark for patients · We are looking for a Clinical Development Lead to join us in our Clinical Development team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta/Raleigh (US) offices. · About the role · As a Clinical Development Lead, ...
20 hours ago
We have an exciting opportunity for a Head of Clinical Development (Ophthalmology) with our partner, · a leading international biopharmaceutical company. This critical hire will drive clinical strategy, planning, and execution for ophthalmology programs, · including late-stage an ...
1 week ago
Clinical Development Manager supports Assistant Medical Director in strengthening performance and consistency of Patient Care Administrators across offices. Key responsibilities include training administrative staff on workflows and best practices. · Coaching PCAs to improve orga ...
2 weeks ago
We are looking for a Vice President of Clinical Development (MD) to lead cross-functional clinical teams for the design and conduct of oncology studies. · ...
1 week ago
We are looking for a Vice President, Clinical Development to lead cross-functional clinical teams. · Lead cross-functional clinical teams. · ...
1 week ago
This role will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs with a dotted line into its sister company, SK Life Science Inc. · Provide clinical and translational leadership to preclinical oncology programs. · Partner closely with ...
1 month ago
We are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. · ...
1 week ago
We seek a top clinical development executive to be responsible for building and executing the clinical development plan for our lead program. · This role will serve as the first dedicated clinical development leader for the program, · and will require excellent communication and ...
3 weeks ago
We are building a network of clinics where autistic children and their families receive life-shaping services that support them to thrive. · Manage multiple clinic buildouts simultaneously from lease execution through certificate of occupancy and handover to operations. · ...
1 month ago
Nursing Professional Development Practitioner Infusion Clinic
Only for registered members
We are seeking a Nursing Professional Development Practitioner to support caregivers in self-reliance and self-development. · Serves as a resource, consultant, and mentor to caregivers. · Collaborates with colleagues to understand goals and learning needs. · ...
1 day ago
We are seeking a Sr/Medical Director, Clinical Development (Medical Monitor) to be the primary sponsor medical person of contact for our clinical trials. · ...
1 week ago
Executive Medical Director, Clinical Development, Breast Cancer
Only for registered members
The Executive Medical Director will be responsible for driving the global clinical development strategy in solid tumors. The incumbent will provide critical input into the strategy and development of Phase 1-4 clinical studies. · ...
1 month ago
Le concepteur principal de systèmes cliniques utilise ses compétences techniques, industrielles et interpersonnelles pour créer des formulaires de rapport de cas (FRC) pour les essais. · ...
1 week ago
The Director of Clinical Services manages day-to-day operations of the clinical department, planning implementation evaluation of clinical care systems patient health outcomes attributable to clinical practice. · ...
1 week ago
The Medical Director & Physician at Blueprint is a senior physician-leader responsible for both direct patient care and clinical leadership across Blueprint's precision and longevity medicine platform. · This role blends hands-on clinical practice with strategic oversight, ensuri ...
1 month ago
We are seeking a dedicated Travel Physical Therapist to join our team in Pacific, MO. This role involves providing exceptional patient care in various clinical settings, assessing patient needs, developing treatment plans and implementing therapeutic interventions.Evaluate and tr ...
3 weeks ago
Registration Educators are responsible for providing orientation to all employees registering patients for services provided by the Health System. · ...
1 week ago