Executive Director, Clinical Development (MD)
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections with real specific content. We have content for About the role (mission statement). Responsibilities (list). Requirements (basic qualifications). Qualifications (preferred qualifications). Skills (maybe from abilities). Benefits (benefits package). Pay (salary range). Schedule (not mentioned, so omit). Also People Leader Accountabilities maybe part of responsibilities? Could be separate but not required heading. We'll include sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay.
We must not repeat job title as heading. No Job ID. Remove boilerplate: EEO, legal, etc. Also remove application instructions, navigation, cookie, etc. Keep substantive info.
We need to preserve all substantive info: mission paragraph, job description summary, responsibilities list, basic qualifications, preferred qualifications, skills (communication, organizational, etc.), benefits (medical, dental, vision, life insurance, bonus, stock, PTO), pay ranges.
We must not invent or summarize away detail. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to ensure we don't include filler like "commensurate with experience". Not present.
Let's extract.
About the role: The first paragraph(s) about mission: "We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows."
That's prose.
Job Description: "We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development: Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio. Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations."
That could be part of About the role or Responsibilities. But we already have Responsibilities section later. We'll keep About the role as mission and maybe brief overview. Could combine but okay.
Responsibilities: list bullet points from "Responsibilities" section.
Let's extract each bullet:
- Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
- Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.
- Routinely represents the assigned products in cross-functional steering and/or governance committees.
- Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
- Leads both written and oral communications with health authorities.
- Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings.
- Where applicable, takes a lead on authoring scientific publications.
- May assist in the clinical evaluation of business development opportunities.
- Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall.
- Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs.
- Typically manages a team of direct reports.
Also People Leader Accountabilities: could be part of Responsibilities or separate but we can include as bullet points under Responsibilities or maybe under Skills? But we have a separate heading for People Leader Accountabilities not in allowed headings. We could incorporate into Responsibilities as bullets.
We'll include them as bullets under Responsibilities.
People Leader Accountabilities bullets:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
We'll add those.
Requirements: Basic Qualifications: "MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment."
We'll put as list? It's a single requirement; could be
but rule says use
- for any list of duties/requirements/benefits. If only one item, still could be
- . We'll do
- MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
Qualifications: Preferred Qualifications list many items. We'll bullet each.
- Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.
- Experience in the biopharma industry is strongly preferred; submissions and conducting phase 2-3 late development studies.
- Experience in multiple myeloma disease area, and cellular therapy therapeutic area is strongly preferred.
- Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
- Multiple years’ line management (direct reports) experience is preferred.
- Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
- Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.
- Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.
- Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- Excellent communication and organizational skills.
- Able to distill complex matters into a clear business case and roadmap for execution.
- Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
- When needed, ability to travel.
We could also include Skills section separate: maybe communication and organizational skills etc. But we already have them in qualifications. However we have a separate Skills heading allowed. We could extract skills: Excellent communication and organizational skills; Able to distill complex matters into a clear business case and roadmap for execution; Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives; When needed, ability to travel. But those are already in qualifications. To avoid duplication, we could put them under Skills and keep qualifications more about experience. But instructions: Preserve ALL substantive information; do not invent or summarize away detail. If we split, we must ensure not to lose any info. We could keep qualifications as experience/education, and skills as separate list. That's fine.
Thus:
Qualifications (Preferred Qualifications) list experience/education etc.
Skills list: Excellent communication and organizational skills; Able to distill complex matters into a clear business case and roadmap for execution; Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives; When needed, ability to travel.
But note that "Excellent communication and organizational skills" and "Able to distill complex matters..." etc are in the Preferred Qualifications list. If we move them to Skills, we would be removing them from Qualifications, which would lose detail unless we keep them also there. But we could keep them in both places? That would duplicate. Better to keep them under Qualifications and not have a separate Skills section unless there are distinct skills not already covered. The instructions: Prefer a few substantive sections over many thin ones. So maybe we skip Skills section and just have Qualifications covering both experience and skills. That's acceptable because Skills heading is optional; we only include if posting has real specific content for it. It does have skills content, but we already covered them under Qualifications. However we could still include Skills section with those items, but then we would be duplicating content, which might be considered repeating detail but not inventing. The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Duplication is not prohibited explicitly, but might be considered unnecessary. Safer to include Skills section with those skill items, and keep Qualifications focusing on experience/education/certifications. Let's split.
Thus:
Qualifications (Preferred Qualifications) list items that are experience/education/certifications:
- Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.
- Experience in the biopharma industry is strongly preferred; submissions and conducting phase 2-3 late development studies.
- Experience in multiple myeloma disease area, and cellular therapy therapeutic area is strongly preferred.
- Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.
- Multiple years’ line management (direct reports) experience is preferred.
- Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
- Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.
- Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.
- Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Skills list:
- Excellent communication and organizational skills.
- Able to distill complex matters into a clear business case and roadmap for execution.
- Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
- When needed, ability to travel.
Now Benefits: The posting says: "This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For Additional Benefits Information, Visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans."
We'll list benefits as bullet points:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives (eligibility may vary based on role)
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental
for prose. We need to ensure we don't include filler like "commensurate with experience". Not present. Let's extract. About the role: The first paragraph(s) about mission: "We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows." That's prose. Job Description: "We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development: Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio. Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations." That could be part of About the role or Responsibilities. But we already have Responsibilities section later. We'll keep About the role as mission and maybe brief overview. Could combine but okay. Responsibilities: list bullet points from "Responsibilities" section. Let's extract each bullet: - Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products. - Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products. - Routinely represents the assigned products in cross-functional steering and/or governance committees. - Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products. - Leads both written and oral communications with health authorities. - Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. - Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans. - Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations. - Presents scientific information at scientific conferences as well as clinical study investigator meetings. - Where applicable, takes a lead on authoring scientific publications. - May assist in the clinical evaluation of business development opportunities. - Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall. - Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs. - Typically manages a team of direct reports. Also People Leader Accountabilities: could be part of Responsibilities or separate but we can include as bullet points under Responsibilities or maybe under Skills? But we have a separate heading for People Leader Accountabilities not in allowed headings. We could incorporate into Responsibilities as bullets. We'll include them as bullets under Responsibilities. People Leader Accountabilities bullets: - Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. - Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. - Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. We'll add those. Requirements: Basic Qualifications: "MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment." We'll put as list? It's a single requirement; could be
but rule says use
- for any list of duties/requirements/benefits. If only one item, still could be
- . We'll do
- MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
- . We'll do