Skip to content

Careers

Job Description

Senior Director of Clinical Research

Region: Americas
Location: Woburn, MA

Posted Date: 09/14/2022

Who We Are

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We are a fast growing, dynamic organization.  We are seeking an experienced Sr Director, Clinical Research.

What You’ll Do

As our Senior Director of Clinical Research, you will lead our clinical trial strategy and execution, and help us build the Clinical Development team as we grow and expand. The ideal candidate will be a motivated and knowledgeable Physician/Scientist who will implement clinical development strategies and execution of clinical studies for the growing Sirtex intertumoral therapies.  You’ll leverage an understanding of the Interventional Radiology disease landscape, unmet clinical need, competitive intelligence, and other salient factors.

Reporting into the Vice President of Clinical Development, the Senior Director of Clinical Research will act as the medical and scientific expert on relevant programs and will collaborate closely with internal project team leads and cross-functional team members to apply emerging data and information to build, revise or update and execute the development strategy as appropriate. We are seeking candidates excited to ramp up quickly in a fast-paced environment, and who are interested in working across multiple Oncology therapeutic areas.  Responsibilities for role include:

  1. Lead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan)
  2. Provide medical and scientific expertise into clinical development and protocol writing activities
  3. Develop the primary and secondary endpoints for efficacy and safety, and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile.
  4. Sit on project teams to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g. start-up and delivery of clinical trials
  5. Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.
  6. Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
  7. Champion of high standards of compliance, ethics and patient safety, putting patients at the center of all actions.
  8. Serve as expert medical and scientific point of contact for regulatory and ethics committee interactions
  9. Plan and participate in data analysis and creation of key study-related outputs such as clinical study reports and publications
  10. Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and leaders.
  11. Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.
  12. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
  13. Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, pharmacology, clinical scientists and development operations.
  14. Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks.
  15. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
  16. Accountability for creating and managing resources within annual Medical Affairs budget, and expenses.

Who You’ll Be

  1. Advanced degree (MD, DO, PhD or PharmD), MD (Radiology, IR, Oncology or Immunology) preferred however not mandatory
  2. 10+ years total experience post (medical) degree, with at least ten years progressive experience in Pharmaceutical or Biotech Industry working in Clinical Research & Development or related fields.
  3. Industry experience in planning, executing and reporting clinical trials with post-marketing experience required.
  4. Prior experience working in a matrix organization as well as cross-functional collaboration with Clinical Development, and Commercial/Marketing departments strongly desired.
  5. Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.
  6. Prior experience with working in an alliance setting strongly preferred.
  7. Global experience, including launch experience strongly desired.
  8. Experience working collaboratively and coordinating with external partners
  9. Demonstrates strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
  10. Demonstrates a strong ability and desire to collaborate with the commercial/marketing organization in an appropriate manner to ensure commercial strategy, plan and execution incorporate medical input and direction. Ensure that all clinical research activities in support of the product adhere to all relevant industry regulations.
  11. Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.
  12. Good working knowledge/experience in GCP is required
  13. Previous experience collaborating and working with Key Opinion Leaders (KOLS) required. Experience in clinical trials and protocol development
    Oncology/Neuroscience and Interventional Radiology experience a plus.
  14. Combination products, 510K and PMA experience is a plus
  15. Knowledge of data analysis and interpretation as and understanding of clinical development safety and pharmacovigilance principles
  16. Leaderships Skills
    1. Approachable
    2. Empowering
    3. Sound judgment
    4. Directs, through line and matrix management, multiple functions and therapeutic areas within Medical Affairs.
    5. Determines organizational structures and operational direction for one or more critical functions within medical affairs.
    6. Is accountable for the overall organizational morale, team effectiveness and talent management
    7. Leads by example and is viewed across the organization as a role model
    8. Serves as spokesperson for the Clinical Research function on highly significant matters as required
    9. Interacts internally and externally with senior management and/ or functional heads requiring negotiation of difficult matters.
    10. Takes on a positive leaderships role when there is ambiguity and little or no direction.
    11. Provides guidance and fosters professional development and growth of direct reports.
    12. Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
    13. Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside Sirtex.

What To Expect at Sirtex

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through career development and training opportunities
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world

Compensation and Benefits 

Sirtex Medical has been named a best-in-class employer in the United States after scoring in the top quartile of large and midsize employers who participated in Gallagher’s 2021 Benefits Strategy & Benchmarking Survey. Sirtex was recognized as an organization that provides innovative solutions for creating organizational structures, workplace policies and total rewards, which inclusively engage and motivate its employees.

Gallagher’s Best-in-Class awards recognize employers that excel in supporting their employees’ physical, emotional, career and financial wellbeing for better organizational outcomes. “The HR team and I are passionate about creating a culture that cares about you and your family’s wellbeing,” said Sirtex Chief Human Resources Officer Cathleen Lowndes. “Our benefit program in the US is special and something I think we can all be proud of. While we still have opportunities to continue investing, we have made several noteworthy upgrades in the past few years.”

Recent upgrades to U.S. Benefits at Sirtex include:

  • Implemented Flexible Work Policy 
  • Added domestic partner benefits
  • Provide adoption assistance resources
  • Upgraded our EAP program to provide you more mental health/wellness options
  • Purchased a la carte hearing benefit
  • Evolved our leave policies to be inclusive 
  • Added an additional medical plan to lower medical premium costs passed on to you
  • Launched Own Your Career – up to $4000/per employee for professional development

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations. Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
  • Physical requirements include sitting, walking, standing for prolonged periods, possible radiation exposure.
  • This position may require up to 30% annual travel (domestic and international).
  • Willingness to:
    • Participate in all relevant formal training events.
    • Observe and comply with all Sirtex corporate policies.
    • Work within, and ensure adherence to quality system procedures, work instructions, and other quality systems.
    • Work within, and ensure adherence to health, safety, and environmental management system procedures, instructions, and other necessary factors.

Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, I accordance with applicable law.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.                                                                                          

Apply Now!

Be part of an amazing team that is helping to save lives, every day.