Senior Director, Clinical Development

Job Description

The Senior Director, Clinical Development (CD) is responsible for providing expert clinical advice across all phases (phase II-IV) of clinical research and will be the responsible clinical lead from the Clinical Development function. They will be responsible for oversight and management of the clinical development execution aspects of clinical development programs. Generally, the role will oversee multiple clinical study programs and/or therapeutic focus areas and establish a resource model to support those activities with both external and internal resources when / as indicated.

This role has the ultimate oversight responsibility for leading CD activities including the design and development of clinical studies, writing in collaboration with Medical Writing, the required clinical documents such as, but not limited to, protocol concept form, clinical study synopsis, clinical study protocol, investigator brochures etc. They are ultimately accountable for the on-time achievement of study and/or program milestones in alignment with the program team strategic imperatives. This position is also the clinical point of contact between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, medical affairs, Key Opinion Leaders, Advisory Boards, etc.

Key Accountabilities

• Clinical Lead
  Acts as the lead clinical representative on Project Teams.
  Act as the key contributor in development of clinical development strategy across multiple indications.

• Develop, review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents.
  Oversee safety monitoring of ongoing clinical studies under their leadership with appropriate support as needed.

• Interact and lead engagements with thought leaders within the respective therapeutic area/indication.
  Track with Program Management the CD deliverables across all clinical studies/projects.

• Lead identifying, contracting and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc.
  Oversee regular maintenance and update of the CD project folders/drives.

• Reviews the informed consent form (ICF); ensures alignment with the related safety sections of the study protocol.
  Develops, reviews and/or approves clinical and safety and monitoring CRF pages.

• Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.

Qualifications

• Education & Experience
  Board licensed MD (or equivalent foreign qualification) in Immunology
  Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity
  Previous experience designing and developing phase 1-4 protocols
  Therapeutic area experience preferred (demonstrable with 2 or more years relevant experience)

• Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.)

• Experience working on a matrix cross-functional clinical team
  Previous project management/clinical operations experience desirable

• Knowledge
  Demonstrated ability to manage multiple and diverse projects concurrently
  Demonstrated ability to develop relationships and generate collaborations
  Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record
  Solid Medical/Scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents
  Working knowledge of statistics, data analysis and data interpretation
  Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB’s and GCP/ICH are necessary
  Excellent written and oral communication skills
  Organizational and cross functional collaboration skills
  Proficient in Microsoft Office Suite of Programs

• Skills & Abilities
  Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs, integrating clinical science, disease area knowledge, and operational requirements
  Incumbent must be able to work with colleagues at all levels of responsibility and authority
  Able to work on multiple projects with aggressive timelines
  Action oriented, flexible, able to adapt to changes in priorities, projects, and daily activities
  Strong presentation skills
  Strong MSP skills

• Physical Requirements
  Up to 20% travel

Benefits

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

The expected base pay range for this position is $285K - $315K. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.